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    <VOL>86</VOL>
    <NO>202</NO>
    <DATE>Friday, October 22, 2021</DATE>
    <UNITNAME>Contents</UNITNAME>
    <CNTNTS>
        <AGCY>
            <EAR>
                Agriculture
                <PRTPAGE P="iii"/>
            </EAR>
            <HD>Agriculture Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Forest Service</P>
            </SEE>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>58636</PGS>
                    <FRDOCBP>2021-23061</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Antitrust Division</EAR>
            <HD>Antitrust Division</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Changes under the National Cooperative Research and Production Act:</SJ>
                <SJDENT>
                    <SJDOC>3D PDF Consortium, Inc., </SJDOC>
                    <PGS>58690</PGS>
                    <FRDOCBP>2021-23101</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>ASTM International, </SJDOC>
                    <PGS>58690</PGS>
                    <FRDOCBP>2021-23105</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Electrified Vehicle and Energy Storage Evaluation, </SJDOC>
                    <PGS>58691</PGS>
                    <FRDOCBP>2021-23098</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>MLCommons Association, </SJDOC>
                    <PGS>58689</PGS>
                    <FRDOCBP>2021-23096</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>ODVA, Inc., </SJDOC>
                    <PGS>58690</PGS>
                    <FRDOCBP>2021-23099</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Robotic Operating System—Military Standards Development Organization, </SJDOC>
                    <PGS>58689-58690</PGS>
                    <FRDOCBP>2021-23095</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Centers Disease</EAR>
            <HD>Centers for Disease Control and Prevention</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Advisory Committee on Immunization Practices, </SJDOC>
                    <PGS>58663-58664</PGS>
                    <FRDOCBP>2021-23222</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Centers Medicare</EAR>
            <HD>Centers for Medicare &amp; Medicaid Services</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>58664-58666</PGS>
                    <FRDOCBP>2021-23107</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Coast Guard</EAR>
            <HD>Coast Guard</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Fire Protection for Recreational Vessels, </DOC>
                    <PGS>58560-58573</PGS>
                    <FRDOCBP>2021-22578</FRDOCBP>
                </DOCENT>
                <SJ>Special Local Regulation:</SJ>
                <SJDENT>
                    <SJDOC>Perrysburg Regatta, Maumee River, Toledo, OH, </SJDOC>
                    <PGS>58575-58577</PGS>
                    <FRDOCBP>2021-23121</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Sacramento Ironman Triathlon, American River and Sacramento River, Sacramento, CA, </SJDOC>
                    <PGS>58573-58575</PGS>
                    <FRDOCBP>2021-23026</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Port Access Route Study:</SJ>
                <SJDENT>
                    <SJDOC>Approaches to the Chesapeake Bay, Virginia, </SJDOC>
                    <PGS>58684-58685</PGS>
                    <FRDOCBP>2021-23103</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Commerce</EAR>
            <HD>Commerce Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Economic Analysis Bureau</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Economic Development Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Industry and Security Bureau</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>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Membership of the Performance Review Board, </DOC>
                    <PGS>58637-58638</PGS>
                    <FRDOCBP>2021-23046</FRDOCBP>
                      
                    <FRDOCBP>2021-23053</FRDOCBP>
                </DOCENT>
                <DOCENT>
                    <DOC>Membership of the Performance Review Board for the Office of the Secretary, </DOC>
                    <PGS>58636-58637</PGS>
                    <FRDOCBP>2021-23055</FRDOCBP>
                </DOCENT>
            </CAT>
        </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>58644-58645</PGS>
                    <FRDOCBP>2021-23079</FRDOCBP>
                      
                    <FRDOCBP>2021-23080</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Comptroller</EAR>
            <HD>Comptroller of the Currency</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Libor Self-Assessment, </SJDOC>
                    <PGS>58723-58725</PGS>
                    <FRDOCBP>2021-23056</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Copyright Royalty Board</EAR>
            <HD>Copyright Royalty Board</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <DOCENT>
                    <DOC>Determination of Rates and Terms for Making and Distributing Phonorecords (Phonorecords IV), </DOC>
                    <PGS>58626-58627</PGS>
                    <FRDOCBP>2021-23097</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Defense Department</EAR>
            <HD>Defense Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>58645-58646</PGS>
                    <FRDOCBP>2021-23110</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Drug</EAR>
            <HD>Drug Enforcement Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Bulk Manufacturer of Controlled Substances Application:</SJ>
                <SJDENT>
                    <SJDOC>Chattem Chemicals, </SJDOC>
                    <PGS>58691</PGS>
                    <FRDOCBP>2021-23037</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Groff NA Hemplex, LLC, </SJDOC>
                    <PGS>58692</PGS>
                    <FRDOCBP>2021-23034</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Organic Consultants, LLC. DBA Cascade Chemistry, </SJDOC>
                    <PGS>58692</PGS>
                    <FRDOCBP>2021-23038</FRDOCBP>
                </SJDENT>
                <SJ>Importer of Controlled Substances Application:</SJ>
                <SJDENT>
                    <SJDOC>Mycrodose Therapeutics, </SJDOC>
                    <PGS>58691-58692</PGS>
                    <FRDOCBP>2021-23036</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Novitium Pharma, LLC, </SJDOC>
                    <PGS>58692-58693</PGS>
                    <FRDOCBP>2021-23032</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Economic Analysis Bureau</EAR>
            <HD>Economic Analysis Bureau</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Advisory Committee, </SJDOC>
                    <PGS>58638</PGS>
                    <FRDOCBP>2021-23018</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Federal Economic Statistics Advisory Committee, </SJDOC>
                    <PGS>58638-58639</PGS>
                    <FRDOCBP>2021-23019</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Economic Development</EAR>
            <HD>Economic Development Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Petitions by Firms for Determination of Eligibility to Apply for Trade Adjustment Assistance, </DOC>
                    <PGS>58639</PGS>
                    <FRDOCBP>2021-23017</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Education Department</EAR>
            <HD>Education Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Magnet Schools Assistance Program—Government Performance and Results Act Table Form, </SJDOC>
                    <PGS>58646-58647</PGS>
                    <FRDOCBP>2021-23044</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>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>58647</PGS>
                    <FRDOCBP>2021-23050</FRDOCBP>
                </DOCENT>
            </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; Sacramento Metro Area; 2008 8-Hour Ozone Nonattainment Area Requirements, </SJDOC>
                    <PGS>58581-58592</PGS>
                    <FRDOCBP>2021-22661</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>California; San Diego Air Pollution Control District, </SJDOC>
                    <PGS>58593-58595</PGS>
                    <FRDOCBP>2021-22885</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <PRTPAGE P="iv"/>
                    <SJDOC>California; South Coast Air Quality Management District; Stationary Source Permits, </SJDOC>
                    <PGS>58592-58593</PGS>
                    <FRDOCBP>2021-22884</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Nevada; Las Vegas Valley; Second 10-Year Carbon Monoxide Limited Maintenance Plan, </SJDOC>
                    <PGS>58579-58581</PGS>
                    <FRDOCBP>2021-22714</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Wisconsin; Attainment Plan for the Rhinelander Sulfur Dioxide Nonattainment Area, </SJDOC>
                    <PGS>58577-58579</PGS>
                    <FRDOCBP>2021-22601</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Air Quality State Implementation Plans; Approvals and Promulgations:</SJ>
                <SJDENT>
                    <SJDOC>Arizona; Base Year Emissions Inventories for the 2015 Ozone Standards; Phoenix-Mesa and Yuma Nonattainment Areas, </SJDOC>
                    <PGS>58630-58635</PGS>
                    <FRDOCBP>2021-22662</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>California; Air Resources Board; Volatile Organic Compounds, </SJDOC>
                    <PGS>58627-58630</PGS>
                    <FRDOCBP>2021-22716</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Alternate Polychlorinated Biphenyls Extraction Methods and Polychlorinated Biphenyls Cleanup and Disposal Regulations, </DOC>
                    <PGS>58730-58762</PGS>
                    <FRDOCBP>2021-19305</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>TSCA Mercury Inventory Reporting, </SJDOC>
                    <PGS>58651-58652</PGS>
                    <FRDOCBP>2021-23020</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>User Fees for the Administration of the Toxic Substances Control Act, </SJDOC>
                    <PGS>58653-58654</PGS>
                    <FRDOCBP>2021-23025</FRDOCBP>
                </SJDENT>
                <SJ>Certain New Chemicals:</SJ>
                <SJDENT>
                    <SJDOC>Receipt and Status Information for September 2021, </SJDOC>
                    <PGS>58658-58662</PGS>
                    <FRDOCBP>2021-23085</FRDOCBP>
                </SJDENT>
                <SJ>Environmental Impact Statements; Availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Weekly Receipt, </SJDOC>
                    <PGS>58654</PGS>
                    <FRDOCBP>2021-23057</FRDOCBP>
                </SJDENT>
                <SJ>Pesticide Product Registration:</SJ>
                <SJDENT>
                    <SJDOC>Interim Decisions and Case Closures for Several Pesticides, </SJDOC>
                    <PGS>58656-58658</PGS>
                    <FRDOCBP>2021-23041</FRDOCBP>
                </SJDENT>
                <SJ>Pesticide Registration Review:</SJ>
                <SJDENT>
                    <SJDOC>Proposed Interim Decisions for Several Pesticides, </SJDOC>
                    <PGS>58654-58656</PGS>
                    <FRDOCBP>2021-23043</FRDOCBP>
                </SJDENT>
                <SJ>Proposed Consent Decree:</SJ>
                <SJDENT>
                    <SJDOC>Clean Air Act Citizen Suit, </SJDOC>
                    <PGS>58652-58653</PGS>
                    <FRDOCBP>2021-23042</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Farm Credit</EAR>
            <HD>Farm Credit Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Standards of Conduct, </DOC>
                    <PGS>58559-58560</PGS>
                    <FRDOCBP>2021-23059</FRDOCBP>
                      
                    <FRDOCBP>2021-23062</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Aviation</EAR>
            <HD>Federal Aviation Administration</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Airspace Designations and Reporting Points:</SJ>
                <SJDENT>
                    <SJDOC>Anvik, AK, </SJDOC>
                    <PGS>58611-58613</PGS>
                    <FRDOCBP>2021-22547</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Bethel, AK, </SJDOC>
                    <PGS>58604-58605</PGS>
                    <FRDOCBP>2021-22675</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Bettles, AK, </SJDOC>
                    <PGS>58613-58615</PGS>
                    <FRDOCBP>2021-22776</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Gulkana, AK, </SJDOC>
                    <PGS>58606-58607, 58609-58611</PGS>
                    <FRDOCBP>2021-22585</FRDOCBP>
                      
                    <FRDOCBP>2021-22778</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>King Salmon, AK, </SJDOC>
                    <PGS>58608-58609</PGS>
                    <FRDOCBP>2021-22586</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Vicinity of Franklin, VA, </SJDOC>
                    <PGS>58607</PGS>
                    <FRDOCBP>2021-22676</FRDOCBP>
                </SJDENT>
                <SJ>Airworthiness Directives:</SJ>
                <SJDENT>
                    <SJDOC>Airbus Helicopters, </SJDOC>
                    <PGS>58600-58604</PGS>
                    <FRDOCBP>2021-22462</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Airbus SAS Airplanes, </SJDOC>
                    <PGS>58597-58600</PGS>
                    <FRDOCBP>2021-22785</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Energy</EAR>
            <HD>Federal Energy Regulatory Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Application:</SJ>
                <SJDENT>
                    <SJDOC>Larry Lempka, </SJDOC>
                    <PGS>58650-58651</PGS>
                    <FRDOCBP>2021-23067</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Combined Filings, </DOC>
                    <PGS>58648-58649</PGS>
                    <FRDOCBP>2021-23113</FRDOCBP>
                      
                    <FRDOCBP>2021-23114</FRDOCBP>
                </DOCENT>
                <SJ>Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations:</SJ>
                <SJDENT>
                    <SJDOC>Hecate Energy Highland LLC, </SJDOC>
                    <PGS>58647-58648</PGS>
                    <FRDOCBP>2021-23111</FRDOCBP>
                </SJDENT>
                <SJ>Inviting Post-Workshop Comments:</SJ>
                <SJDENT>
                    <SJDOC>Electric Transmission Incentives Policy Under Section 219 of the Federal Power Act, </SJDOC>
                    <PGS>58649-58650</PGS>
                    <FRDOCBP>2021-23112</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Labor</EAR>
            <HD>Federal Labor Relations Authority</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Senior Executive Service Performance Review Board, </DOC>
                    <PGS>58662</PGS>
                    <FRDOCBP>2021-23066</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Railroad</EAR>
            <HD>Federal Railroad Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>58721-58723</PGS>
                    <FRDOCBP>2021-23104</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Reserve</EAR>
            <HD>Federal Reserve System</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Change in Bank Control:</SJ>
                <SJDENT>
                    <SJDOC>Acquisitions of Shares of a Bank or Bank Holding Company, </SJDOC>
                    <PGS>58662</PGS>
                    <FRDOCBP>2021-23100</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Transit</EAR>
            <HD>Federal Transit Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>58723</PGS>
                    <FRDOCBP>2021-23065</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Food and Drug</EAR>
            <HD>Food and Drug Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation, </SJDOC>
                    <PGS>58666-58670</PGS>
                    <FRDOCBP>2021-23086</FRDOCBP>
                </SJDENT>
                <SJ>Determination of Regulatory Review Period for Purposes of Patent Extension:</SJ>
                <SJDENT>
                    <SJDOC>NUBEQA, </SJDOC>
                    <PGS>58670-58672</PGS>
                    <FRDOCBP>2021-23074</FRDOCBP>
                </SJDENT>
                <SJ>Determination that Products Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness:</SJ>
                <SJDENT>
                    <SJDOC>ROBAXIN and ROBAXIN-750 (Methocarbamol), Oral Tablets, 500 Milligrams and 750 Milligrams, and Other Drug Products, </SJDOC>
                    <PGS>58674-58675</PGS>
                    <FRDOCBP>2021-23084</FRDOCBP>
                </SJDENT>
                <SJ>Guidance:</SJ>
                <SJDENT>
                    <SJDOC>Data Standards for Drug and Biological Product Submissions Containing Real-World Data, </SJDOC>
                    <PGS>58672-58674</PGS>
                    <FRDOCBP>2021-23081</FRDOCBP>
                </SJDENT>
                <SJ>Withdrawal of Approval of 216 Abbreviated New Drug Applications:</SJ>
                <SJDENT>
                    <SJDOC>Fresenius USA, Inc., et al., </SJDOC>
                    <PGS>58675-58681</PGS>
                    <FRDOCBP>2021-23075</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Forest</EAR>
            <HD>Forest Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Environmental Impact Statements; Availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Proposed Husky 1 North Dry Ridge Phosphate Mine, Caribou County, Idaho, </SJDOC>
                    <PGS>58686-58687</PGS>
                    <FRDOCBP>2021-23027</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>General Services</EAR>
            <HD>General Services Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Office of Federal High-Performance Green Buildings; Green Building Advisory Committee, </SJDOC>
                    <PGS>58663</PGS>
                    <FRDOCBP>2021-23068</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Health and Human</EAR>
            <HD>Health and Human Services Department</HD>
            <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>Food and Drug Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>National Institutes of Health</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Homeland</EAR>
            <HD>Homeland Security Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Coast Guard</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Indian Affairs</EAR>
            <HD>Indian Affairs Bureau</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Indian Gaming:</SJ>
                <SJDENT>
                    <SJDOC>Approval of Tribal-State Class III Gaming Compact in the State of Washington, </SJDOC>
                    <PGS>58685</PGS>
                    <FRDOCBP>2021-23064</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>
                Industry
                <PRTPAGE P="v"/>
            </EAR>
            <HD>Industry and Security Bureau</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Export Administration Regulations:</SJ>
                <SJDENT>
                    <SJDOC>Clarifications of Availability and Expansion of Restrictions on Availability of License Exception Strategic Trade Authorization, </SJDOC>
                    <PGS>58615-58626</PGS>
                    <FRDOCBP>2021-21954</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Interior</EAR>
            <HD>Interior Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Indian Affairs Bureau</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Land Management Bureau</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>National Park Service</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>International Trade Adm</EAR>
            <HD>International Trade Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Civil Nuclear Trade Advisory Committee, </SJDOC>
                    <PGS>58640-58641</PGS>
                    <FRDOCBP>2021-23033</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Quarterly Update to Annual Listing of Foreign Government Subsidies on Articles of Cheese Subject to an In-Quota Rate of Duty, </DOC>
                    <PGS>58639-58640</PGS>
                    <FRDOCBP>2021-23077</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Justice Department</EAR>
            <HD>Justice Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Antitrust Division</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Drug Enforcement Administration</P>
            </SEE>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Service Contract Inventory, </DOC>
                    <PGS>58693</PGS>
                    <FRDOCBP>2021-23014</FRDOCBP>
                </DOCENT>
            </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>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Veterans Employment and Training Service</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Land</EAR>
            <HD>Land Management Bureau</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Application:</SJ>
                <SJDENT>
                    <SJDOC>Withdrawal Extension and Opportunity for Public Meeting, Lemhi Pass National Historic Landmark, Idaho and Montana, </SJDOC>
                    <PGS>58685-58686</PGS>
                    <FRDOCBP>2021-23076</FRDOCBP>
                </SJDENT>
                <SJ>Environmental Impact Statements; Availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Proposed Husky 1 North Dry Ridge Phosphate Mine, Caribou County, Idaho, </SJDOC>
                    <PGS>58686-58687</PGS>
                    <FRDOCBP>2021-23027</FRDOCBP>
                </SJDENT>
                <SJ>Intent to Prepare a Resource Management Plan Amendment Environmental Assessment, Recreation Area Management Plan, and Travel Management Plan:</SJ>
                <SJDENT>
                    <SJDOC>Logandale Trails, Clark County, NV, </SJDOC>
                    <PGS>58687-58688</PGS>
                    <FRDOCBP>2021-23083</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Library</EAR>
            <HD>Library of Congress</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Copyright Royalty Board</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>National Institute</EAR>
            <HD>National Institutes of Health</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Center for Scientific Review, </SJDOC>
                    <PGS>58682-58683</PGS>
                    <FRDOCBP>2021-23082</FRDOCBP>
                      
                    <FRDOCBP>2021-23090</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Eye Institute, </SJDOC>
                    <PGS>58684</PGS>
                    <FRDOCBP>2021-23045</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Heart, Lung, and Blood Institute, </SJDOC>
                    <PGS>58683-58684</PGS>
                    <FRDOCBP>2021-23089</FRDOCBP>
                      
                    <FRDOCBP>2021-23091</FRDOCBP>
                </SJDENT>
                <SJ>Prospective Grant of Exclusive Patent Commercialization License:</SJ>
                <SJDENT>
                    <SJDOC>CD28H Domain-Containing Chimeric Antigen Receptors and Methods of Use, </SJDOC>
                    <PGS>58681-58682</PGS>
                    <FRDOCBP>2021-23092</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Oceanic</EAR>
            <HD>National Oceanic and Atmospheric Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Fisheries of the Exclusive Economic Zone Off Alaska:</SJ>
                <SJDENT>
                    <SJDOC>Pacific Ocean Perch in the Western Regulatory Area of the Gulf of Alaska, </SJDOC>
                    <PGS>58596</PGS>
                    <FRDOCBP>2021-23102</FRDOCBP>
                </SJDENT>
                <SJ>Fisheries of the Northeastern United States:</SJ>
                <SJDENT>
                    <SJDOC>Atlantic Bluefish Fishery; Quota Transfers from NJ to RI and MD to NC, </SJDOC>
                    <PGS>58595-58596</PGS>
                    <FRDOCBP>2021-23054</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Permits:</SJ>
                <SJDENT>
                    <SJDOC>Taking of Threatened or Endangered Marine Mammals Incidental to Commercial Fishing Operations, </SJDOC>
                    <PGS>58641-58644</PGS>
                    <FRDOCBP>2021-23047</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Park</EAR>
            <HD>National Park Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>National Register of Historic Places:</SJ>
                <SJDENT>
                    <SJDOC>Pending Nominations and Related Actions, </SJDOC>
                    <PGS>58688-58689</PGS>
                    <FRDOCBP>2021-23015</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Science</EAR>
            <HD>National Science Foundation</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Permit Modification Received Under the Antarctic Conservation Act, </DOC>
                    <PGS>58698</PGS>
                    <FRDOCBP>2021-22206</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Nuclear Regulatory</EAR>
            <HD>Nuclear Regulatory Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Establishment of Atomic Safety and Licensing Board:</SJ>
                <SJDENT>
                    <SJDOC>Duke Energy Carolinas, LLC, </SJDOC>
                    <PGS>58703</PGS>
                    <FRDOCBP>2021-23109</FRDOCBP>
                </SJDENT>
                <SJ>Exemption; Issuance:</SJ>
                <SJDENT>
                    <SJDOC>Holtec Decommissioning International, LLC Pilgrim Nuclear Power Station Exemption from Certain Low-Level Waste Shipment Tracking Requirements, </SJDOC>
                    <PGS>58699-58701</PGS>
                    <FRDOCBP>2021-23088</FRDOCBP>
                </SJDENT>
                <SJ>Intent to Conduct Scoping Process and Prepare Environmental Impact Statement:</SJ>
                <SJDENT>
                    <SJDOC>Florida Power and Light Co. St. Lucie Plant Units 1 and 2, </SJDOC>
                    <PGS>58701-58703</PGS>
                    <FRDOCBP>2021-23073</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Meetings; Sunshine Act, </DOC>
                    <PGS>58698-58699</PGS>
                    <FRDOCBP>2021-23247</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Occupational Safety Health Adm</EAR>
            <HD>Occupational Safety and Health Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Application for Expansion of Recognition:</SJ>
                <SJDENT>
                    <SJDOC>Bay Area Compliance Laboratories Corp., </SJDOC>
                    <PGS>58694-58696</PGS>
                    <FRDOCBP>2021-23030</FRDOCBP>
                </SJDENT>
                <SJ>Requests for Nominations:</SJ>
                <SJDENT>
                    <SJDOC>Federal Advisory Council on Occupational Safety and Health, </SJDOC>
                    <PGS>58693-58694</PGS>
                    <FRDOCBP>2021-23029</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Postal Regulatory</EAR>
            <HD>Postal Regulatory Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>New Postal Product, </DOC>
                    <PGS>58703-58704</PGS>
                    <FRDOCBP>2021-23070</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Presidential Documents</EAR>
            <HD>Presidential Documents</HD>
            <CAT>
                <HD>EXECUTIVE ORDERS</HD>
                <SJ>Education:</SJ>
                <SJDENT>
                    <SJDOC>White House Initiative on Advancing Educational Equity, Excellence, and Economic Opportunity for Black Americans; Establishment (EO 14050), </SJDOC>
                    <PGS>58551-58557</PGS>
                    <FRDOCBP>2021-23224</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Securities</EAR>
            <HD>Securities and Exchange Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Asset Management Advisory Committee, </SJDOC>
                    <PGS>58712-58713</PGS>
                    <FRDOCBP>2021-23072</FRDOCBP>
                </SJDENT>
                <SJ>Self-Regulatory Organizations; Proposed Rule Changes:</SJ>
                <SJDENT>
                    <SJDOC>Cboe C2 Exchange, Inc., </SJDOC>
                    <PGS>58706-58709</PGS>
                    <FRDOCBP>2021-23023</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Cboe Exchange, Inc., </SJDOC>
                    <PGS>58709-58712</PGS>
                    <FRDOCBP>2021-23022</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Long-Term Stock Exchange, Inc., </SJDOC>
                    <PGS>58713-58715</PGS>
                    <FRDOCBP>2021-23024</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>The Options Clearing Corp., </SJDOC>
                    <PGS>58704-58706</PGS>
                    <FRDOCBP>2021-23021</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Social</EAR>
            <HD>Social Security Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Cost-of-Living Increase and Other Determinations for 2022, </DOC>
                    <PGS>58715-58721</PGS>
                    <FRDOCBP>2021-23031</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>
                Surface Transportation
                <PRTPAGE P="vi"/>
            </EAR>
            <HD>Surface Transportation Board</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Exemption:</SJ>
                <SJDENT>
                    <SJDOC>Trackage Rights; BNSF Railway Co.; Union Pacific Railroad Co., </SJDOC>
                    <PGS>58721</PGS>
                    <FRDOCBP>2021-23071</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 Railroad Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Federal Transit Administration</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Treasury</EAR>
            <HD>Treasury Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Comptroller of the Currency</P>
            </SEE>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>58725-58727</PGS>
                    <FRDOCBP>2021-23115</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Veteran Affairs</EAR>
            <HD>Veterans Affairs Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Application for Chapter 23 Burial Benefits, </SJDOC>
                    <PGS>58727-58728</PGS>
                    <FRDOCBP>2021-23106</FRDOCBP>
                </SJDENT>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Voluntary Service National Advisory Committee, </SJDOC>
                    <PGS>58727</PGS>
                    <FRDOCBP>2021-23087</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Veterans Employment</EAR>
            <HD>Veterans Employment and Training Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>VETS' Jobs for Veterans State Grants Program Reporting, </SJDOC>
                    <PGS>58696-58698</PGS>
                    <FRDOCBP>2021-23028</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <PTS>
            <HD SOURCE="HED">Separate Parts In This Issue</HD>
            <HD>Part II</HD>
            <DOCENT>
                <DOC>Environmental Protection Agency, </DOC>
                <PGS>58730-58762</PGS>
                <FRDOCBP>2021-19305</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>86</VOL>
    <NO>202</NO>
    <DATE>Friday, October 22, 2021</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <RULES>
        <RULE>
            <PREAMB>
                <PRTPAGE P="58559"/>
                <AGENCY TYPE="F">FARM CREDIT ADMINISTRATION</AGENCY>
                <CFR>12 CFR Parts 611 and 621</CFR>
                <RIN>RIN 3052-AC44</RIN>
                <SUBJECT>Standards of Conduct</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Farm Credit Administration.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule; technical amendments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>On September 13, 2021, the Farm Credit Administration (FCA) issued a final rule on standards of conduct for directors and employees of Farm Credit System (System) institutions. That final rule document inadvertently failed to update two cross-references to the standards of conduct rules contained in parts 611 and 621 of the same chapter. This document makes those changes to the cross-references contained in parts 611 and 621.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective January 1, 2023.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Antonya Brown, Technical Editor, Office of General Counsel, Farm Credit Administration, McLean, VA 22102-5090, (703) 883-4020, TTY (703) 883-4056.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    On Monday, September 13, 2021, FCA published in the 
                    <E T="04">Federal Register</E>
                     (86 FR 50956) a final rule amending FCA regulations governing standards of conduct for System director and employees, excluding the Federal Agricultural Mortgage Corporation, located in part 612 of chapter VI, title 12 of the Code of Federal Regulations. The rulemaking included renumbering certain sections of the existing standards of conduct provisions. In issuing the final rule, corresponding updates to standards of conduct regulatory references were inadvertently omitted. This document changes those cross-references to FCA standards of conduct contained §§ 611.1153(c)(3) and 621.30 of the same chapter.
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 12 CFR Parts 611 and 621</HD>
                    <P>Accounting, Agriculture, Banks, Banking, Conflicts of interest, Crime, Reporting and recordkeeping requirements, Investigations, Rural areas.</P>
                </LSTSUB>
                <P>Accordingly, 12 CFR parts 611 and 621 are corrected by making the following correcting amendments:</P>
                <PART>
                    <HD SOURCE="HED">PART 611—ORGANIZATION</HD>
                </PART>
                <REGTEXT TITLE="12" PART="611">
                    <AMDPAR>1. The authority citation for part 611 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>Secs. 1.2, 1.3, 1.4, 1.5, 1.12, 1.13, 2.0, 2.1, 2.2, 2.10, 2.11, 2.12, 3.0, 3.1, 3.2, 3.3, 3.7, 3.8, 3.9, 4.3A, 4.12, 4.12A, 4.15, 4.20, 4.21, 4.25, 4.26, 4.27, 4.28A, 5.9, 5.17, 5.25, 7.0-7.13, 8.5(e) of the Farm Credit Act (12 U.S.C. 2002, 2011, 2012, 2013, 2020, 2021, 2071, 2072, 2073, 2091, 2092, 2093, 2121, 2122, 2123, 2124, 2128, 2129, 2130, 2154a, 2183, 2184, 2203, 2208, 2209, 2211, 2212, 2213, 2214, 2243, 2252, 2261, 2279a-2279f-1, 2279aa-5(e)); secs. 411 and 412 of Pub. L. 100-233, 101 Stat. 1568, 1638; secs. 414 of Pub. L. 100-399, 102 Stat. 989, 1004.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart J—Unincorporated Business Entities</HD>
                    <SECTION>
                        <SECTNO>§ 611.1153 </SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="12" PART="611">
                    <AMDPAR>2. In § 611.1153, amend paragraph (c)(3) by removing the phrase “in compliance with the standards of conduct rules in §§ 612.2130 through 612.2270” and adding in its place the phrase “in compliance with the standards of conduct rules in 12 CFR 612, subpart A of this chapter.”</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 621—ACCOUNTING AND REPORTING REQUIREMENTS</HD>
                </PART>
                <REGTEXT TITLE="12" PART="621">
                    <AMDPAR>3. The authority citation for part 621 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>Secs. 4.12(b)(5), 4.14, 4.14A, 4.14D, 5.17, 5.22A, 8.11 of the Farm Credit Act (12 U.S.C. 2183, 2202, 2202a, 2202d, 2252, 2257a, 2279aa-11); sec. 514 of Pub. L. 102-552.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart E—Auditor Independence</HD>
                    <SECTION>
                        <SECTNO>§ 621.30 </SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="12" PART="621">
                    <AMDPAR>4. In § 621.30, amend the last sentence by removing the phrase “§ 612.2260 of this chapter” and adding in its place the phrase “§ 612.2180 of this chapter.”</AMDPAR>
                    <STARS/>
                </REGTEXT>
                <SIG>
                    <DATED>Dated: October 19, 2021. </DATED>
                    <NAME>Dale Aultman,</NAME>
                    <TITLE>Secretary, Farm Credit Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23059 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6705-01-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">FARM CREDIT ADMINISTRATION</AGENCY>
                <CFR>12 CFR Part 612</CFR>
                <RIN>RIN 3052-AC44</RIN>
                <SUBJECT>Standards of Conduct</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Farm Credit Administration.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notification of effective date.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Farm Credit Administration (FCA) issued a final rule amending our regulations governing standards of conduct of directors and employees of the Farm Credit System (System) institutions to require each System institution to have or develop a Standards of Conduct Program based on core principles.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The final rule amending subpart A of 12 CFR part 612, published on September 13, 2021 (86 FR 50956), is effective on January 1, 2023.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P> </P>
                    <P>
                        <E T="03">Technical information:</E>
                         Lori Markowitz, Senior Policy Analyst, Office of Regulatory Policy, Farm Credit Administration, (703) 883-4487, TTY (703) 883-4056, 
                        <E T="03">ORPMailbox@fca.gov.</E>
                    </P>
                    <P>
                        <E T="03">Legal information:</E>
                         Laura McFarland, Senior Counsel, Office of General Counsel, Farm Credit Administration, (703) 883-4020, TTY (703) 883-4056.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>On September 13, 2021, FCA issued a final rule adopting amendments to our regulations governing standards of conduct of System directors and employees, excluding the Federal Agricultural Mortgage Corporation. The final rule requires each System institution to have or develop a Standards of Conduct Program based on core principles which serve as the foundation for ethical conduct, including requiring each System institution to adopt a Code of Ethics and address the responsibilities of directors, employees, and Standards of Conduct Officials.</P>
                <P>
                    In accordance with 12 U.S.C. 2252(c)(1), the effective date of the rule may be no earlier than 30 days from the date of publication in the 
                    <E T="04">Federal Register</E>
                     during which either or both 
                    <PRTPAGE P="58560"/>
                    Houses of Congress are in session. The Act does not prevent FCA from identifying an effective date that provides more than the minimum required amount of time. The Standards of Conduct rule was expected to be effective on or about November 3, 2021, but the FCA Board voted on October 18, 2021 to delay the effective date to January 1, 2023. FCA believes postponing the effective date will allow System institutions the necessary time to develop and implement the required Standards of Conduct policies, as well as train directors and employees on the new requirements.
                </P>
                <P>We are inviting the public to comment on the change in effective date. You may submit comments on this action within 30 days of this notice by any of the following methods:</P>
                <P>
                    • 
                    <E T="03">Email:</E>
                     Send us an email at 
                    <E T="03">reg-comm@fca.gov</E>
                    .
                </P>
                <P>
                    • 
                    <E T="03">Agency Website: http://www.fca.gov</E>
                    . Once you are at the website, select the “I want to . . .” field near the top of the page; select “comment on a pending regulation” from the dropdown menu; and click “Go”.
                </P>
                <P>
                    • 
                    <E T="03">Mail:</E>
                     Kevin J. Kramp, Director, Office of Regulatory Policy, Farm Credit Administration, 1501 Farm Credit Drive, McLean, VA 22102-5090.
                </P>
                <P>If FCA receives significant adverse comments on delaying the effective date for this rule, FCA will publish a notice withdrawing this notice that will indicate how the agency will proceed.</P>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>Dale Aultman,</NAME>
                    <TITLE>Secretary, Farm Credit Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23062 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6705-01-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <SUBAGY>Coast Guard</SUBAGY>
                <CFR>33 CFR Parts 1 and 175</CFR>
                <CFR>46 CFR Part 25</CFR>
                <DEPDOC>[Docket No. USCG-2018-0099]</DEPDOC>
                <RIN>RIN 1625-AC41</RIN>
                <SUBJECT>Fire Protection for Recreational Vessels</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Coast Guard, Department of Homeland Security (DHS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Coast Guard is amending fire extinguishing equipment regulations for recreational vessels that are propelled or controlled by propulsion machinery. This rule relieves owners of these recreational vessels from certain inspection, maintenance, and recordkeeping requirements that are more suited for commercial vessels. To make it easier to find these regulations, this rule also relocates the regulations to another part of the Code of Federal Regulations.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This final rule is effective April 20, 2022.</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-2018-0099 in the “SEARCH” box and click “SEARCH.”
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For information about this document, call or email Jeffrey Decker, Office of Auxiliary and Boating Safety, Boating Safety Division (CG-BSX-2), Coast Guard; telephone 202-372-1507, email 
                        <E T="03">RBSinfo@uscg.mil.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Table of Contents for Preamble </HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Abbreviations</FP>
                    <FP SOURCE="FP-2">II. Purpose, Basis, and Regulatory History</FP>
                    <FP SOURCE="FP1-2">A. Purpose</FP>
                    <FP SOURCE="FP1-2">B. Basis and Regulatory History</FP>
                    <FP SOURCE="FP-2">III. Background</FP>
                    <FP SOURCE="FP-2">IV. Discussion of Comments and Changes</FP>
                    <FP SOURCE="FP1-2">A. National Fire Protection Association (NFPA) Comments</FP>
                    <FP SOURCE="FP1-2">B. Burden Estimates of NFPA Requirements on Recreational Boaters</FP>
                    <FP SOURCE="FP1-2">C. Vagueness of the Coast Guard's “Good and Serviceable” Standard</FP>
                    <FP SOURCE="FP1-2">D. Health and Safety Risks</FP>
                    <FP SOURCE="FP1-2">E. Frequency of Portable Fire Extinguisher Inspections</FP>
                    <FP SOURCE="FP1-2">F. Relocation of Fire Extinguishing Requirements From 46 CFR to 33 CFR</FP>
                    <FP SOURCE="FP1-2">G. Classes of Portable Fire Extinguishers Required To Be Carried</FP>
                    <FP SOURCE="FP1-2">H. Number of Portable Fire Extinguishers Required To Be Carried</FP>
                    <FP SOURCE="FP1-2">I. Standard for Fixed Fire Extinguishing Systems</FP>
                    <FP SOURCE="FP1-2">J. Requirements for Coast Guard-Documented Vessels and State-Registered Vessels</FP>
                    <FP SOURCE="FP1-2">K. Need for Greater Public Awareness</FP>
                    <FP SOURCE="FP-2">V. Discussion of the Rule</FP>
                    <FP SOURCE="FP1-2">A. What This Rule Does</FP>
                    <FP SOURCE="FP1-2">B. Changes From the Proposed Rule</FP>
                    <FP SOURCE="FP-2">VI. Regulatory Analyses</FP>
                    <FP SOURCE="FP1-2">A. Regulatory Planning and Review</FP>
                    <FP SOURCE="FP1-2">B. Small Entities</FP>
                    <FP SOURCE="FP1-2">C. Assistance for Small Entities</FP>
                    <FP SOURCE="FP1-2">D. Collection of Information</FP>
                    <FP SOURCE="FP1-2">E. Federalism</FP>
                    <FP SOURCE="FP1-2">F. Unfunded Mandates</FP>
                    <FP SOURCE="FP1-2">G. Taking of Private Property</FP>
                    <FP SOURCE="FP1-2">H. Civil Justice Reform</FP>
                    <FP SOURCE="FP1-2">I. Protection of Children</FP>
                    <FP SOURCE="FP1-2">J. Indian Tribal Governments</FP>
                    <FP SOURCE="FP1-2">K. Energy Effects</FP>
                    <FP SOURCE="FP1-2">L. Technical Standards</FP>
                    <FP SOURCE="FP1-2">M. Environment</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Abbreviations </HD>
                <EXTRACT>
                    <FP SOURCE="FP-1">CATEX Categorical exclusion</FP>
                    <FP SOURCE="FP-1">COMDTINST Commandant Instruction</FP>
                    <FP SOURCE="FP-1">CFR Code of Federal Regulations</FP>
                    <FP SOURCE="FP-1">DHS Department of Homeland Security</FP>
                    <FP SOURCE="FP-1">Fire Protection rule Harmonization of Standards for Fire Protection, Detection, and Extinguishing Equipment (81 FR 48219, July 22, 2016)</FP>
                    <FP SOURCE="FP-1">FR Federal Register</FP>
                    <FP SOURCE="FP-1">NBSAC National Boating Safety Advisory Council</FP>
                    <FP SOURCE="FP-1">NFPA National Fire Protection Association</FP>
                    <FP SOURCE="FP-1">NFPA 10 NFPA 10 Standard for Portable Fire Extinguishers, 2010 edition</FP>
                    <FP SOURCE="FP-1">NPRM Notice of proposed rulemaking</FP>
                    <FP SOURCE="FP-1">OMB Office of Management and Budget</FP>
                    <FP SOURCE="FP-1">RA Regulatory analysis</FP>
                    <FP SOURCE="FP-1">§ Section </FP>
                    <FP SOURCE="FP-1">U.S.C. United States Code</FP>
                </EXTRACT>
                <HD SOURCE="HD1">II. Purpose, Basis, and Regulatory History</HD>
                <HD SOURCE="HD2">A. Purpose</HD>
                <P>The Coast Guard is amending portable fire extinguishing equipment requirements for recreational vessels that are propelled or controlled by propulsion machinery. We are relieving owners of these recreational vessels from certain inspection, maintenance, and recordkeeping requirements of National Fire Protection Association (NFPA) 10 (2010 edition). These requirements are more suited for commercial vessels. This rule does not alter standards for commercial vessels including vessels carrying passengers for hire, or have any effect on recreational vessels that do not use propulsion machinery.</P>
                <P>This rule also moves fire extinguishing equipment rules for recreational vessels from subpart 25.30 (Fire Extinguishing Equipment) of subchapter C (Uninspected Vessels) of title 46 of the Code of Federal Regulations (CFR) to part 175 of subchapter S (Boating Safety) of title 33, where other recreational vessel rules already exist.</P>
                <HD SOURCE="HD2">B. Basis and Regulatory History</HD>
                <P>
                    The Secretary of Homeland Security is authorized by 46 U.S.C. 4302(a)(2) to prescribe regulations requiring the installation, carrying, or use of firefighting equipment and prohibiting the installation, carrying, or use of equipment that does not conform to the safety standards established under section 4302. The Secretary of Homeland Security has delegated this authority to the Coast Guard by Department of Homeland Security (DHS) Delegation No. 0170.1(II)(92)(b). The Commandant has redelegated this authority to the Assistant Commandant for Response Policy as described in 33 CFR 1.05-1(d).
                    <PRTPAGE P="58561"/>
                </P>
                <P>
                    The Coast Guard published a notice of proposed rulemaking (NPRM) in the 
                    <E T="04">Federal Register</E>
                     (FR) on May 13, 2019, “Fire Protection for Recreational Vessels.” 
                    <SU>1</SU>
                    <FTREF/>
                     The NPRM proposed to relieve recreational vessel owners from the inspection, maintenance, and recordkeeping requirements of NFPA 10 and to consolidate recreational boating safety requirements into 33 CFR chapter I, subchapter S. Instead of applying NFPA 10 and requiring monthly visual inspections, annual maintenance, and recordkeeping, we proposed that portable fire extinguishers on recreational vessels be maintained in “good and serviceable” condition. The NPRM solicited comments and provided a 60-day comment period that ended on July 12, 2019. Based on those comments, we have made changes in this final rule, as discussed in section IV.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         84 FR 20827, May 13, 2019.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">III. Background</HD>
                <P>
                    On July 22, 2016, the Coast Guard published the final rule, “Harmonization Standards for Fire Protection, Detection, and Extinguishing Equipment” (the “Fire Protection rule”) in the 
                    <E T="04">Federal Register</E>
                    .
                    <SU>2</SU>
                    <FTREF/>
                     The Fire Protection rule revised Coast Guard fire safety requirements for uninspected vessels (46 CFR chapter I, subchapter C) to meet international and common industry standards. Among the revisions, the Coast Guard required vessel owners to comply with NFPA 10.
                    <SU>3</SU>
                    <FTREF/>
                     This standard requires vessel owners and operators to complete monthly visual inspections of portable fire extinguishers,
                    <SU>4</SU>
                    <FTREF/>
                     perform annual maintenance of portable fire extinguishers,
                    <SU>5</SU>
                    <FTREF/>
                     and maintain records of the inspections and maintenance.
                    <SU>6</SU>
                    <FTREF/>
                     The Coast Guard allowed the required monthly inspections to be carried out by the vessel owner, operator, person-in-charge, or a designated member of the crew, rather than by a certified person as required in NFPA 10.
                    <SU>7</SU>
                    <FTREF/>
                     The Fire Protection rule also allowed these individuals to perform annual maintenance on non-rechargeable (also known as “disposable”) extinguishers but retained the NFPA 10 requirement that rechargeable extinguishers be maintained by a certified person such as a licensed servicing agency.
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         81 FR 48219, July 22, 2016 (effective August 22, 2016).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         The NFPA is a non-profit organization that develops technical codes and consensus standards to eliminate death, injury, property, and economic loss due to fire, electrical, and related hazards. NFPA 10 lists requirements to ensure that portable fire extinguishers will work as intended to provide a first line of defense against fires of limited size.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         NFPA 10 section 7.2.1.2.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         NFPA 10 section 7.3.1.1.1.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         NFPA 10 sections 7.2.4 and 7.3.3.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         33 CFR 145.01(b)(2).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         33 CFR 145.01(b) and NFPA section 7.1.2.1.
                    </P>
                </FTNT>
                <P>
                    The only exception to these inspection, recordkeeping, and maintenance requirements was for extinguishers built before 1965, in which the Coast Guard maintained their previous and separate inspection and maintenance requirements specific to those types of extinguishers.
                    <SU>9</SU>
                    <FTREF/>
                     The Coast Guard's changes to the inspection and maintenance requirements in the Fire Protection rule were intended to apply to all vessels, including recreational vessels, in order to align inspection and maintenance requirements with common industry practice for fire extinguisher maintenance.
                    <SU>10</SU>
                    <FTREF/>
                     (The NPRM for this action stated that the NFPA 10 requirements were “unintentionally” applied to recreational boaters in 2016 by the Fire Protection rule. It would have been more correct to say that 2016 rule did not recognize the full burden on recreational vessels.) They were also intended to provide a more complete set of maintenance and inspection requirements than what currently existed in Coast Guard regulations for extinguishers manufactured since 1965.
                    <SU>11</SU>
                    <FTREF/>
                     In the regulatory analysis accompanying the Fire Protection rule, we stated that we did not anticipate recreational vessel owners would incur any additional costs due to these provisions.
                    <SU>12</SU>
                    <FTREF/>
                     After the rule published, however, we realized the requirements to visually inspect and maintain non-rechargeable fire extinguishers as described in NFPA 10, and to keep records of those activities in compliance with NFPA 10, actually do impose a burden on recreational vessel owners and operators.
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         46 CFR 25.30-10(h); 46 CFR 72.05-1(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         81 FR 48219, 48229 (“[UL 711 and NFPA 10:2010] . . . apply to all the affected populations carrying portable and semi-portable fire extinguishers listed in Table 4, including recreational vessel. These provisions eliminate a Coast Guard-specific rating system for fire extinguisher classifications in favor of the classifications specified in the relevant national industry standards.”)
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         81 FR 48219, 48230 (third column, lines 16-21), July 22, 2016.
                    </P>
                </FTNT>
                <P>
                    On October 22, 2016, the National Boating Safety Advisory Council (NBSAC) recommended that the Coast Guard remove the NFPA 10 recordkeeping requirements from recreational vessels and consolidate recreational vessel fire protection and boating safety requirements into 33 CFR chapter I, subchapter S (33 CFR parts 173-199).
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         NBSAC Resolution 2016-96-02 (available at 
                        <E T="03">https://homeport.uscg.mil/Lists/Content/Attachments/498/NBSAC%2096%20Resolution%202016-96-02%20Fire%20Extinguishers%20-%20Signed.pdf</E>
                        ).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">IV. Discussion of Comments and Changes</HD>
                <P>The Coast Guard received submissions from 14 commenters in response to the NPRM. In general, most commenters supported the proposed rule, but a few expressed reservations. We summarize and address these comments below.</P>
                <HD SOURCE="HD2">A. National Fire Protection Association (NFPA) Comments</HD>
                <P>The NFPA is a private, not-for-profit organization. They published the NFPA 10 standard that the Coast Guard incorporated by reference into our regulations through the Fire Protection rule.</P>
                <HD SOURCE="HD3">Removal of NFPA 10 Requirements</HD>
                <P>The NFPA does not support the Coast Guard removing the NFPA 10 portable fire extinguisher inspection, maintenance, and recordkeeping requirements for recreational vessels. They are concerned that if the monthly inspection requirement is removed, vessel owners will not perform necessary inspections and maintenance. They recommend that the Coast Guard keep the NFPA 10 requirements for monthly inspection and recordkeeping to ensure that portable fire extinguishers on recreational vessels are in good working order.</P>
                <P>We disagree with the NFPA's position. The Coast Guard's alternative “good and serviceable” standard, as provided for in this rule in 33 CFR 175.310, maintains safety preparedness standards while reducing prescriptive burdens on recreational vessel owners and operators. Under this standard, logged inspections are not required, but the owner or operator must ensure all fire extinguishers are “readily accessible” and in “good and serviceable” condition. In response to the comments on the NPRM, we have expanded the regulatory text to explain what “good and serviceable” means. This final rule clarifies that “good and serviceable” means that a portable fire extinguisher on board a recreational vessel:</P>
                <P>• Is charged, and indicates it is charged if the extinguisher has a pressure gauge reading or indicator;</P>
                <P>
                    • Has a pin lock that is firmly in place;
                    <PRTPAGE P="58562"/>
                </P>
                <P>• Does not show visible signs of significant corrosion or damage; and</P>
                <P>• Has a discharge nozzle that is clean and free of obstructions.</P>
                <P>Thus, the “good and serviceable” standard of this rule maintains the substantive requirements of NFPA 10 without the monthly inspection and recordkeeping requirements. Prior to the Fire Protection rule, the Coast Guard had never required recreational boaters to maintain a record of inspection for any piece of safety equipment (such as personal flotation devices, visual distress signals, and so on). Because the Coast Guard is unaware of any empirical data showing fire-extinguisher failure to be a significant cause for concern on recreational vessels, and because the Coast Guard is unaware of any empirical data showing that maintaining these records has prevented fire-extinguisher failure, we do not believe that requiring boaters to maintain these records significantly increases public safety. This new standard will continue to ensure that portable fire extinguishers are in good working order and ready for immediate use without imposing unnecessary burdens on the public.</P>
                <HD SOURCE="HD3">Burdensome Nature of Inspections</HD>
                <P>The NFPA asserts that recordkeeping requirements for portable fire extinguisher inspections are not burdensome to recreational boaters. The Coast Guard disagrees because the NFPA requirements have the boat owner perform monthly inspections even when the vessel is not in use. The NFPA requirement does not relieve the recreational boat owner from performing monthly inspections when the vessel is in non-use, storage or winter layup. This is a change from how the boating public normally uses their vessels, and results in an unwarranted burden. Removing the NFPA 10 recordkeeping requirements will generate an estimated timesaving component of approximately 12 minutes per year per fire extinguisher (1 minute per month per fire extinguisher). This estimate only includes the cost to the boater of recording the fire extinguisher's condition. It does not include the costs to the boater of traveling to the vessel when it is not in use. We did not estimate the travel costs because we do not have any data on the average travel time to their vessel when not in use. Additionally, we lack data on the number of months a vessel might be in use. See our response in section IV.B of this document for additional information on the burden estimate.</P>
                <HD SOURCE="HD3">Relocation of the Requirements in the CFR</HD>
                <P>The NFPA supports moving fire extinguishing requirements from 46 CFR 25 to 33 CFR 175.</P>
                <HD SOURCE="HD2">B. Burden Estimates of NFPA Requirements on Recreational Boaters</HD>
                <P>Several commenters supported removing the NFPA 10 recordkeeping requirements; however, other commenters (including the NFPA) said these recordkeeping requirements should be retained for recreational vessels because they are not a burden to these boaters. The Coast Guard disagrees with retaining the recordkeeping requirements due to the time burden associated with NFPA 10's recordkeeping requirements. We estimate that removing this requirement will reduce recordkeeping burdens by 12 minutes per year per fire extinguisher (1 minute per month per fire extinguisher), plus travel time when the vessel is not in use. One commenter asserted that the Coast Guard's estimate of 12 minutes per year was too high because some boats are not in use all 12 months of the year and a more accurate burden estimate would be 6 to 8 minutes per year. We note that the monthly inspection requirement of NFPA 10 does not provide exceptions for when a boat is not in use, and, as a result, current regulations require 12 minutes per year of recordkeeping, plus travel time when the boat is not otherwise in use. However, 12 minutes is an estimated average and we recognize that some people may spend more time and some people may spend less time to comply with these recordkeeping requirements.</P>
                <HD SOURCE="HD2">C. Vagueness of the Coast Guard's “Good and Serviceable” Standard</HD>
                <P>This rule requires portable fire extinguishers to be unexpired and in “good and serviceable” condition. Two commenters expressed concern that the phrase “good and serviceable” is vague. The Coast Guard revised the proposed rule in response to these concerns, but notes that the phrase “good and serviceable” is already in use for portable fire extinguishers, such as in the existing provision in 46 CFR 25.30-10 for portable fire extinguishers built before 1965, and also in other sections of the CFR for both recreational vessels and commercial vessels such as in 46 CFR 25.30-10, 142.240, and 180.200. In response to these comments, we updated our regulatory text in 33 CFR 175.310(a) to elaborate further on the requirements. This final rule clarifies that “good and serviceable” means that a portable fire extinguisher:</P>
                <P>• Is charged, and indicates it is charged if the extinguisher has a pressure gauge reading or indicator;</P>
                <P>• Has a pin lock that is firmly in place;</P>
                <P>• Does not show visible signs of significant corrosion or other damage; and</P>
                <P>• Has a discharge nozzle that is clean and free of obstructions.</P>
                <HD SOURCE="HD2">D. Health and Safety Risks</HD>
                <P>
                    Three commenters expressed concern that removing the NFPA 10 inspection and recordkeeping requirements could lead to unsafe conditions. The Coast Guard is not aware of any evidence showing this change will decrease safety. Serious injury to recreational boaters (injury requiring medical care beyond first aid) resulting from portable fire extinguisher failure is rare. According to the Boating Accident Report Database, between 2008 and 2017 only three such injuries occurred, and no injuries are known to have been caused directly by equipment failure.
                    <SU>14</SU>
                    <FTREF/>
                     Our alternative standard, as amended in this final rule (see 33 CFR 175.310), ensures that portable fire extinguishers on recreational vessels are not expired, readily accessible, and in good working order. We used the “good and serviceable” standard elsewhere in our regulations, without a decrease to safety.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">https://bard.knightpoint.systems/PublicInterface/Report1.aspx.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD2">E. Frequency of Portable Fire Extinguisher Inspections</HD>
                <P>The revised rule does not set a frequency at which vessel owners or operators must inspect fire extinguishers. One commenter stated that portable fire extinguishers on recreational vessels should be inspected at least once a year, and two commenters stated they should be inspected monthly. Under the Coast Guard's revised standard, a recreational vessel is in compliance only if the portable fire extinguishers are unexpired, readily accessible, and in “good and serviceable” condition. The Coast Guard believes that this will improve flexibility while maintaining safety, especially for vessels that may not be in use all year. The Coast Guard's primary concern is ensuring the safety of the boating public while the vessel is in use.</P>
                <HD SOURCE="HD2">F. Relocation of Fire Extinguishing Requirements From 46 CFR to 33 CFR</HD>
                <P>
                    Most commenters supported the move of regulations from 46 CFR part 25, 
                    <PRTPAGE P="58563"/>
                    subpart 25.30 to 33 CFR part 175, subpart E. One commenter disagreed, however, stating that title 33 of the CFR was relatively unmonitored and unmanaged compared to title 46. We disagree with the assertion that title 33 of the CFR is relatively unmonitored. The Coast Guard enforces the agency's regulations regardless of where they are in the CFR.
                </P>
                <HD SOURCE="HD2">G. Classes of Portable Fire Extinguishers Required To Be Carried</HD>
                <P>
                    The Coast Guard currently requires approved Class B portable fire extinguishers to be carried on board recreational vessels. Portable fire extinguishers with a Class B rating are effective against flammable liquid fires such as gasoline, petroleum, greases, oils, oil-based paints, solvents, and alcohols. Multiple commenters stated that the Coast Guard should require either additional single-class portable fire extinguishers (such as Class A or Class C) or combination-class portable fire extinguishers (such as A-B-C) on all recreational vessels to adequately address other types of fires. Class A fires involve ordinary combustibles such as trash, wood, and paper, whereas Class C fires involve energized electrical sources such as computers, servers, motors, transformers, and appliances. The Coast Guard does not agree that portable fire extinguishers capable of extinguishing Class A and Class C fires should be required to be carried on board recreational vessels. The predominant fire hazards for recreational vessels come from fuel and fuel vapors, which are Class B hazards.
                    <SU>15</SU>
                    <FTREF/>
                     Moreover, approved Class B extinguishers already have additional ratings to extinguish both Class A and Class C fires.
                    <SU>16</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         The USCG Boating Accident Report Database (BARD) (out of the 1,175 fire/explosion related incidents over the 5-year period 2015-2019, for which cause was known, 68 percent (n=799) of them were fuel-related).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         The Coast Guard's review of listed portable fire extinguishers by Underwriters Laboratory indicates there are no listed portable fire extinguishers that have only a B rating; all B-rated portable fire extinguishers have additional A, C, or both capabilities.
                    </P>
                </FTNT>
                <P>Over the past 50 years, since the Federal Boat Safety Act of 1971 established the current Coast Guard fire extinguisher carriage requirements, we have found no data showing the current fire extinguisher requirements for recreational boating are insufficient. Previous Coast Guard requirements for the hand-held B-I or B-II (and the current requirements for 5-B and 20-B) approved portable fire extinguishers have shown to be an acceptable minimum standard for the recreational boater. Additionally, strict Federal recreational boat-building requirements, such as backfire flame control, ventilation, and electrical and mechanical national safety and manufacturing standards, also reduce the probability or severity of boat fires.</P>
                <HD SOURCE="HD2">H. Number of Portable Fire Extinguishers Required To Be Carried</HD>
                <P>One commenter stated that the Coast Guard should require more portable fire extinguishers on recreational vessels. This comment is outside the scope of this rulemaking. As previously stated, there is no data showing that the current fire extinguisher requirements for recreational boating are insufficient.</P>
                <HD SOURCE="HD2">I. Standard for Fixed Extinguishing Systems</HD>
                <P>One commenter expressed concern that the proposal would eliminate a standard for maintaining fixed fire extinguishing systems on recreational vessels. NFPA 10 applies only to portable fire extinguishers. The removal of NFPA 10's application to recreational vessels through this final rule will neither impose nor remove maintenance standards for fixed fire extinguishing systems.</P>
                <HD SOURCE="HD2">J. Requirements for Coast Guard-Documented Vessels and State-Registered Vessels</HD>
                <P>One commenter asked the Coast Guard to clearly distinguish any differences in requirements between Coast Guard-documented recreational vessels and state-registered vessels in this rule. This rule does not contain any different requirements for state-registered vessels and Coast Guard-documented recreational vessels. Longstanding carriage requirements for portable fire extinguishers are based on specific criteria, including the type of fuel, storage of fuel (portable or fixed and installed), type of construction (open or closed), and length of vessel. This rulemaking does not make changes to those requirements.</P>
                <HD SOURCE="HD2">K. Need for Greater Public Awareness</HD>
                <P>
                    A few commenters stated that there is a need for greater public awareness of portable fire extinguisher safety and boating safety in general. One commenter recommended awareness campaigns to highlight how to use fire suppression equipment. One commenter stated that there was inadequate public awareness of best fire safety practices in the recreational boating community. One commenter stated that Federal boating safety awareness materials could be improved, although the commenter did not provide specific examples. The Coast Guard works with non-profit boating safety organizations and our state boating partners to distribute information to the recreational boating public.
                    <SU>17</SU>
                    <FTREF/>
                     The Coast Guard will consider what other information campaigns could be appropriate. The Boating Safety Division in the Coast Guard's Office of Auxiliary and Boating Safety is dedicated to reducing loss of life, injuries, and property damage that occurs on U.S. waterways by improving the knowledge, skill, and abilities of recreational boaters.
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">www.uscgboating.org.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">V. Discussion of the Rule</HD>
                <HD SOURCE="HD2">A. What This Rule Does</HD>
                <P>The goal of this rule is to move recreational vessel fire extinguishing equipment requirements from the commercial vessel fire extinguishing equipment requirements section in title 46 of the CFR and to consolidate recreational vessel-specific requirements into one part in title 33 of the CFR, which will not contain the NFPA 10 visual inspection, annual maintenance, and recordkeeping requirements for recreational vessels. This change affects only recreational vessels with propulsion machinery and will not affect commercial vessels, including vessels carrying passengers for hire.</P>
                <HD SOURCE="HD3">1. Transfer of Recreational Vessel Fire Extinguishing Equipment Regulations From 46 CFR to 33 CFR</HD>
                <P>
                    The Coast Guard is creating a new subpart E (Fire Protection Equipment) under part 175 (Equipment Requirements) in 33 CFR chapter I, subchapter S (Boating Safety) for fire extinguishing equipment requirements for recreational vessels. This consolidates these regulations into part 175 where other recreational vessel-specific rules are located. The fire extinguishing equipment requirements added to subpart E will be the same as in current 46 CFR subpart 25.30, but will be modified as discussed in sections V.A(2) and (3) of this document. The Coast Guard is limiting the applicability of this new subpart to recreational vessels, as defined in 33 CFR 175.3, which are propelled or controlled by propulsion machinery. The Coast Guard is also revising the applicability section in 46 CFR 25.30-1 so that the fire extinguishing equipment regulations in subpart 25.30 will not apply to recreational vessels as defined in 33 CFR 175.3. We are only changing the applicability of the fire extinguishing equipment regulations in 
                    <PRTPAGE P="58564"/>
                    46 CFR part 25, subpart 25.30; we are not changing the applicability of any other requirements in 46 CFR part 25. The other requirements in 46 CFR part 25 (such as life preservers, navigation lights, and ventilation) are not being changed.
                </P>
                <HD SOURCE="HD3">2. Removal of Requirement for Recreational Vessels To Comply With NFPA 10</HD>
                <P>The Coast Guard is modifying the fire extinguishing equipment requirements added to 33 CFR part 175, subpart E to remove the requirement for recreational vessels to comply with NFPA 10. Instead of applying the NFPA 10 requirements, we are requiring that portable fire extinguishers be maintained in “good and serviceable” condition. Both the “good and serviceable” standard and the NFPA 10 requirements (monthly visual inspection, annual maintenance, and recordkeeping) exist to achieve the same result, namely that portable and semi-portable fire extinguishers be in working condition in the event of a fire. However, the NFPA 10 requirements are very specific and require burdensome recordkeeping. The new “good and serviceable” standard relieves owners and operators of recreational vessels of following the specifics of NFPA 10 while allowing them flexibility in how to achieve the same result. By doing so, the Coast Guard is making it easier and less costly for recreational vessel owners to maintain the fire protection equipment on their vessel.</P>
                <HD SOURCE="HD3">3. Clarifying Edits, Updating Outdated Text, and Administrative Edits</HD>
                <P>The Coast Guard is modifying the fire extinguishing equipment requirements added to 33 CFR part 175, subpart E to clarify the regulatory language, update outdated information, and make technical amendments.</P>
                <P>We are making the following edits and updates:</P>
                <P>• Removing the reference to the no longer published Commandant Instruction (COMDTINST) M16714.3 (new 33 CFR 175.305);</P>
                <P>• Changing the terms “motorboats” and “motor vessels,” as currently used in subpart 25.30, to the clearer terms “recreational vessels 65 feet and less in length” and “recreational vessels more than 65 feet in length,” respectively. This change aligns the language used in the new subpart E with the terminology already used in 33 CFR part 175, and reinforces the intent of subpart E to apply the requirements only to recreational vessels, and not all motorboats and motor vessels. It also makes the distinction between the two vessel size categories clearer, allowing readers to more easily find the fire extinguishing equipment requirements appropriate for a particular type of vessel;</P>
                <P>• Adding new language to clarify acronyms and update cross-references to 46 CFR subpart 25.30. For example, we are replacing the “B.H.P.” acronym with “brake horsepower” and updating references to point clearly towards 46 CFR instead of chapter I; and</P>
                <P>• Modifying the language moved from 46 CFR subpart 25.30 to refer to recreational vessels by model years, as opposed to contracting or manufacturing dates. The latter terms are applicable to commercial vessels only. This change allows the recreational boating community to more easily identify their vessel requirements and aligns with industry and market naming practices.</P>
                <P>This rule does not change any exemptions that already apply to recreational vessels. The Coast Guard is retaining all the existing recreational fire extinguishing equipment exemptions, such as those for vessels manufactured before August 22, 2016, and the fire extinguishing equipment exemptions for vessels manufactured before November 19, 1952, as provided in 46 CFR 25.30-80 and 46 CFR 25.30-90. Where we previously allowed exemptions for vessels manufactured or contracted before August 22, 2016, we will now apply the same exemptions to recreational vessels with model years before 2017. Where regulations previously exempted vessels manufactured or contracted before November 19, 1952, we will now apply those exemptions to recreational vessels with model years before 1953. The 2016 exemption is part of the transition from old Coast Guard weight-based ratings, to Underwriter Laboratory (UL) performance-based ratings, and grandfathered existing extinguishers on boats so they do not have to replace their existing extinguishers. However, the 2016 exemption still requires new extinguishers to meet the new requirements. Changing or not allowing this exemption would result in a burden for the recreational boater community.</P>
                <P>We are also retaining the exemption in 46 CFR 25.30-20(a) that allows recreational vessels less than 26 feet in length, propelled by outboard motors and not carrying passengers for hire, to not have to carry portable fire extinguishers if the construction of the vessel excludes the entrapment of explosive or flammable gases or vapors.</P>
                <HD SOURCE="HD2">B. Changes From the Proposed Rule</HD>
                <HD SOURCE="HD3">Clerical Amendments</HD>
                <P>The Coast Guard made several small stylistic and clerical amendments. In 33 CFR 1.08-1(a)(8), we added a cross reference to 33 CFR part 175, subpart E, to reflect the relocation and renumbering of regulations made by this final rule. No substantive requirements result from this change. We made corrections to capitalization, changing “Figure” to “figure” and “Table” to “table” when these words appear in regulatory text. These changes appear in 33 CFR 175.320(a)(1), Note 1 to Figure 1 to 33 CFR 175.320(a), Note 2 to Figure 2 to 33 CFR 175.320(a), 33 CFR 175.320(b)(1), 33 CFR 175.320(b)(2), 33 CFR 175.320(c), and 33 CFR 175.380(a). We also made a small stylistic change to word requirements in the singular rather than the plural for greater clarity. We changed “Recreational vessels” to “A recreational vessel” and amended the sentence structure accordingly where necessary in 33 CFR 175.320(a)(1), 33 CFR 175.320(b)(1), and 33 CFR 175.390.</P>
                <HD SOURCE="HD3">“Good and Serviceable” Standard</HD>
                <P>Based on public comments, the Coast Guard reorganized the fire extinguisher requirements in 33 CFR 175.310, clarified the phrase “good and serviceable,” and removed the requirements that extinguishers be maintained in accordance with manufacturer's instructions. In order to clarify the phrase “good and serviceable,” we added that the fire extinguisher lock pin must firmly be in place, the discharge nozzle be clean and free of obstruction, the extinguisher must not show signs of significant corrosion or damage and the portable fire extinguisher must be readily accessible. The Coast Guard has a long history of using the phrase “good and serviceable” for portable fire extinguishers, such as in the existing 46 CFR 25.30-10 for portable fire extinguishers built before 1965, and also in other sections of the CFR for both recreational vessels and commercial vessels such as 46 CFR 25.30-10, 142.240, or 180.200.</P>
                <HD SOURCE="HD3">Modified Definition of “Model Year”</HD>
                <P>
                    We have modified the definition for “model year” in 33 CFR 175.3 from what we proposed in the NPRM. The definition in the NPRM had the model year run from August 1st until July 31st of the following year. The revised definition has the model year run from June 1st until July 31st of the following year. This change was made to conform with the definition of “model year” found in 46 U.S.C. 4302(e)(1).
                    <PRTPAGE P="58565"/>
                </P>
                <HD SOURCE="HD1">VI. 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 these statutes or Executive orders.</P>
                <HD SOURCE="HD2">A. Regulatory Planning and Review</HD>
                <P>Executive Orders 12866 (Regulatory Planning and Review) and 13563 (Improving Regulation and Regulatory Review) 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 (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.</P>
                <P>The Office of Management and Budget (OMB) has not designated this rule a significant regulatory action under section 3(f) of Executive Order 12866. Accordingly, OMB has not reviewed it. A regulatory analysis (RA) with details on the estimated cost savings of this rule follows.</P>
                <P>This final rule removes requirements imposed by the 2016 Fire Protection rule. The Fire Protection rule's requirements for fire extinguishing equipment in 46 CFR subpart 25.30 of chapter I, subchapter C (Uninspected Vessels) applied the NFPA 10 monthly visual inspection, annual maintenance, and recordkeeping requirements to both recreational and commercial vessels. This final rule removes the NFPA 10 recordkeeping and monthly visual inspection requirements together with the requirement for annual maintenance from the recreational vessel community. Instead of the prescriptive monthly inspection requirement, including a recordkeeping component, the Coast Guard is promulgating this final rule, which contains performance standards to require that portable fire extinguishers be kept in a “good and serviceable” condition without any recordkeeping requirement. By doing so, the Coast Guard is making it easier for recreational vessel owners to maintain their fire protection equipment. The final rule does not change the fire extinguishing equipment requirements for commercial vessels in 46 CFR subpart 25.30 or any other recreational vessel requirements.</P>
                <P>The Coast Guard published a proposed rule on May 13, 2019. We made some changes to the regulatory analysis because of the comments received during the comment period for the NPRM. These revisions did not affect the conclusions or estimates made by the RA. We reorganized and modified the regulatory language that appeared in the NPRM to improve clarity in this final rule. The Coast Guard is amending regulatory language in new 46 CFR 175.310(a) and (b). The Coast Guard added the language “on board and readily accessible” into section 175.310(a)(1). We introduced new language into section 175.310(a)(4) to specify the meaning of “good and serviceable.” The regulatory assessment of costs and benefits of the NPRM remains unchanged. Table 1 summarizes the changes to the regulatory text from the proposed rule to this final rule and the resulting impact on the regulatory analysis.</P>
                <GPOTABLE COLS="3" OPTS="L2,nj,i1" CDEF="s75,r100,r100">
                    <TTITLE>Table 1—Changes From NPRM to Final Rule</TTITLE>
                    <BOXHD>
                        <CHED H="1">NPRM's regulatory text</CHED>
                        <CHED H="1">Final rule's regulatory text</CHED>
                        <CHED H="1">Resulting impact on the RA</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01" O="xl">33 CFR 1.08-1(a)(8). 46 CFR 25.30 fire extinguishers;</ENT>
                        <ENT O="xl">33 CFR 1.08-1(a)(8). 46 CFR subpart 25.30, Fire Extinguishing Equipment and 33 CFR part 175, subpart E, Fire Protection Equipment.</ENT>
                        <ENT>No impact. Cross-references updated/added to account for changes made by this final rule.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">33 CFR 175.3 Definitions. Model year means the period beginning August 1 of any year and ending on July 31 of the following year. Each model year is designated by the year in which it ends</ENT>
                        <ENT>
                            33 CFR 175.3. 
                            <E T="03">Model year</E>
                             means the period beginning June 1 of a year and ending on July 31 of the following year and being designated by the year in which it ends
                        </ENT>
                        <ENT>No impact. Amendment made to align definitions with those is 46 USC.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">33 CFR 175.310(b)(1). Be carried aboard the vessel</ENT>
                        <ENT>33 CFR 175.310(a)(1). Be on board and readily accessible</ENT>
                        <ENT>No impact. Amendments made for consistency with other required safety equipment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">33 CFR 175.310(b)(4). Be maintained in accordance with the manufacturer's instructions</ENT>
                        <ENT>33 CFR 175.310(a)(4). Be maintained in “good and serviceable” working condition, meaning: (i) It has a pressure gauge reading or indicator in the operable range or position, if there is one; (ii) The lock pin is firmly in place; (iii) The discharge nozzle is clean and free of obstruction; and (iv) The portable fire extinguisher does not show visible signs of significant corrosion or damage</ENT>
                        <ENT>No impact. Amendment is made to align the rulemaking with its intended non-prescriptive goal-based objective instead of the prescriptive regimen of NFPA 10 compliance. This amendment also aligns with the public comment request for further clarity and maintains an equivalent preventative safety standard with NFPA 10.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The Coast Guard promulgates regulations to protect the environment and human and marine life and to ensure safe boating practices. The Fire Protection rule applied the NFPA 10 monthly visual inspection, annual maintenance, and recordkeeping requirements to both recreational and commercial vessels. This created a new regulatory requirement for recreational vessels. This final rule will remove the NFPA 10 recordkeeping and monthly visual inspection requirements together with the requirement for annual maintenance from the recreational vessel community. The final rule replaces those NFPA 10 requirements with the requirement for portable fire extinguishers to be kept in “good and serviceable” condition. The final rule does not change the fire extinguishing equipment requirements for commercial vessels in 46 CFR part 25, subpart 25.30, or any other recreational vessel requirements.</P>
                <P>
                    Additionally, the Coast Guard will correct an incongruity in our vessel safety equipment regulations by shifting recreational vessel fire extinguishing equipment requirements from 46 CFR subpart 25.30 (Fire Extinguishing Equipment) to 33 CFR part 175 into a new subpart E (Equipment Requirements). This reorganization will not alter regulatory requirements for commercial vessels, but will separate recreational vessels from them.
                    <PRTPAGE P="58566"/>
                </P>
                <P>
                    The Coast Guard reviewed available data to determine if any governmental entity was complying with the requirements. Based on a thorough search of State regulations, the Coast Guard found no evidence of the States, the District of Columbia, or territories changing regulations as a result of the Fire Protection rule.
                    <SU>18</SU>
                    <FTREF/>
                     Therefore, the Coast Guard determined that the States, the District of Columbia, and territorial jurisdictions will not need to revise their regulations and, thereby, incur any cost. Additionally, we received no public comment during the comment period for the proposed rule disagreeing with this determination.
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         Per Coast Guard subject matter expert review and communication with State and territorial jurisdictions.
                    </P>
                </FTNT>
                <P>The Coast Guard expects that there are no costs to the regulated public from this rule because this rule replaces the required monthly inspections and recordkeeping with a performance standard that vessel owners can meet in the manner least burdensome to each owner. The primary cost savings of this rule will be from alleviating the regulatory burden placed on the recreational vessel community by the Fire Protection rule, which prescribes compliance with the NFPA 10 inspection, maintenance, and recordkeeping requirements for portable fire extinguishers; this rule replaces the current prescriptive requirements with a performance standard. Table 2 presents a summary of the impacts of this final rule.</P>
                <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="xs80,r150">
                    <TTITLE>Table 2—Summary of Impacts of the Final Rule</TTITLE>
                    <BOXHD>
                        <CHED H="1">Category</CHED>
                        <CHED H="1">Summary</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Applicability</ENT>
                        <ENT>Recreational vessels with propulsion machinery operating in domestic waters are no longer required to comply with the NFPA 10 fire extinguishing equipment requirements.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Affected population</ENT>
                        <ENT>11,052,684 recreational vessels with propulsion machinery operating in domestic waters that are required by existing Coast Guard regulations to carry portable fire extinguishers; 50 States, District of Columbia, and 5 territories that enforce boating safety requirements.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Costs</ENT>
                        <ENT>No Cost.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Cost Savings</ENT>
                        <ENT>Removes the NFPA 10 inspection, maintenance, and recordkeeping requirements for recreational vessels required to carry portable fire extinguishers onboard. Savings equate to 12 minutes per year per fire extinguisher, plus travel time when the vessel is not in use. We do not quantify the cost savings because we do not have information on the number of fire extinguishers per vessel or how many recreational vessel owners have complied with the current NFPA 10 requirements; as a result, we leave this as an unquantified cost savings.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Benefits</ENT>
                        <ENT>Maintains safety preparedness standards while reducing prescriptive burdens, allowing recreational vessel owners and operators to meet the safety requirements in the way best suited for each owner/operator. Additionally, by moving from a prescriptive requirement to a performance standard, this rule maintains safety preparedness standards while allowing recreational vessel owners and operators to meet the safety requirements in the way best suited for each owner/operator. Shifts recreational vessel fire extinguishing equipment requirements from 46 CFR subpart 25.30 to 33 CFR part 175, subpart E, creating a clear distinction between fire extinguishing equipment regulations intended for commercial vessels and those intended for recreational vessels. Removes COMDTINST M16714.3 which is no longer published. This change reduces confusion in reading the regulatory text.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">Affected Population</HD>
                <P>
                    The affected population consists of recreational vessels subject to the NFPA 10 requirements under the current 46 CFR part 25, subpart 25.30 and the 50 states, the District of Columbia, and 5 territories. The Coast Guard used recreational vessel population data from the Coast Guard Office of Auxiliary and Boating Safety's document titled, 
                    <E T="03">2013 Recreational Boating Statistics,</E>
                     for the 2016 Fire Protection rule's RA to estimate the affected population.
                    <SU>19</SU>
                    <FTREF/>
                     For this rule's analysis, the Coast Guard is using the most recently published data from the 
                    <E T="03">2019 Recreational Boating Statistics</E>
                     to identify a population of 11,052,684 registered motorized recreational vessels that will be affected by this final rule.
                    <SU>20</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         Recreational Boating Statistics 2013, table 37 (available at: 
                        <E T="03">https://www.uscgboating.org/assets/1/AssetManager/2013RecBoatingStats.pdf</E>
                        ).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         The NPRM utilized the Recreational Boating Statistics 2016, table 37, which are available at: 
                        <E T="03">https://www.uscgboating.org/library/accident-statistics/Recreational-Boating-Statistics-2016.pdf.</E>
                         This final rule uses the most recent published Recreational Boating Statistics 2019, table 37, which is available at: 
                        <E T="03">https://www.uscgboating.org/library/accident-statistics/Recreational-Boating-Statistics-2019.pdf.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Comments</HD>
                <P>
                    The Coast Guard received 14 comments on the NPRM.
                    <SU>21</SU>
                    <FTREF/>
                     We addressed comments earlier in the preamble (see section IV). Some comments dealt with economic issues or with the regulatory analysis of the rulemaking; we discuss these comments in this section.
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         We received 15 submittals, but comment USCG-2018-0099-0017 was a duplicate of comment USCG-2018-0099-0015.
                    </P>
                </FTNT>
                <P>
                    We received few comments regarding the RA or economic issues. Commenter USCG-2018-0099-0015 wrote, “Brief, monthly inspections are not a burden. Many recreational boats are not in use for the full 12 months of the year so a monthly inspection only would take place perhaps 6 or 8 times a year.” We note that the monthly inspection requirement of NFPA 10 does not provide exceptions for when a boat is not in use; however, 12 minutes is an estimated average and we recognize that some people may spend more time and some people may spend less time on these requirements (see also our response in the 
                    <E T="03">Cost Savings</E>
                     section of the regulatory analysis of this document for additional information on the burden estimate). Commenter USCG-2018-0099-0015 also wrote, “Perhaps the requirement for recordkeeping should be excused but the multiple use of the word burden in the Federal Registers Request for Comment is not at all appropriate when it comes to the fire protection preparations for a recreational boat owner. Inspecting an important piece of marine safety gear is not a burden for a prudent boat owner/operator.” The Coast Guard uses the term of art “burden” as defined in the Paperwork Reduction Act.
                    <SU>22</SU>
                    <FTREF/>
                     Keeping the requirement for inspections without a requirement to record them does not yield greater safety to vessel owners or the public. The final rule establishes performance requirements to ensure the equipment is available in appropriate condition.
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         44 U.S.C. 3502(2).
                    </P>
                </FTNT>
                <P>
                    Commenter USCG-2018-0099-0004 wrote, “Fire extinguishers (both portable and fixed automatic for engine rooms) still need to be inspected at least 
                    <PRTPAGE P="58567"/>
                    annually. Without annual inspections the extinguisher could be inoperable without the vessel owners [sic] knowledge.” The Coast Guard chose not to follow this recommendation because it would create an additional burden for vessel owners. And we believe the final rule's requirement for “good and serviceable” condition would address safety concerns.
                </P>
                <P>We, therefore, adopt the methodology and assumptions for the costs, cost savings and benefits from the NPRM as final. However, we have updated the analysis with a more current estimate of the affected population.</P>
                <HD SOURCE="HD3">Cost and Cost Savings Analysis</HD>
                <P>This final rule proposes 20 changes to the fire extinguishing equipment regulations in 33 CFR part 175, subpart E, and 46 CFR part 25, subpart 25.30. These changes remove the recreational vessel fire extinguishing equipment regulations from 46 CFR part 25, subpart 25.30 (Fire Extinguishing Equipment) to a new subpart E in 33 CFR part 175. This change will include the addition of a new section 175.301 to specify the applicability of subpart E to recreational vessels. It also will include new sections 175.305, 175.310, 175.315, 175.320, 175.380, and 175.390 to reflect requirements previously applied by 46 CFR subpart 25.30, but excluding those that require recreational vessel owners and operators to follow the monthly visual inspection, annual maintenance, and recordkeeping requirements of NFPA 10.</P>
                <P>Overall, there are no costs to the regulated public due to these changes to the regulatory text. We describe the costs, cost savings, and qualitative benefits of these in table 3.</P>
                <GPOTABLE COLS="4" OPTS="L2,nj,p7,7/8,i1" CDEF="s50,r50,r150,r80">
                    <TTITLE>Table 3—Assessment of Impacts (Costs, Cost Savings, and Benefits) of the Final Rule to the Regulated Public</TTITLE>
                    <BOXHD>
                        <CHED H="1">
                            Existing 46 CFR
                            <LI>part 25 §</LI>
                        </CHED>
                        <CHED H="1">
                            New 33 CFR
                            <LI>part 175 §</LI>
                        </CHED>
                        <CHED H="1">Description of change</CHED>
                        <CHED H="1">Impact</CHED>
                    </BOXHD>
                    <ROW EXPSTB="03" RUL="s">
                        <ENT I="21">
                            <E T="02">Definitions</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00" RUL="s">
                        <ENT I="01">§ 25.30-1(b) &amp; (c)</ENT>
                        <ENT>§ 175.3</ENT>
                        <ENT>
                            Add the definition of 
                            <E T="03">Model Year</E>
                             to the section. This change allows the recreational boating community to more easily identify their vessel requirements and aligns with industry and market naming practices
                        </ENT>
                        <ENT>No cost. Qualitative benefit from the elimination of confusion of recreational boat owners attempting to locate the manufacturing date of their boat.</ENT>
                    </ROW>
                    <ROW EXPSTB="03" RUL="s">
                        <ENT I="21">
                            <E T="02">Applicability</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00" RUL="s">
                        <ENT I="01">§ 25.30-1</ENT>
                        <ENT>§ 175.301</ENT>
                        <ENT>Incorporate existing text from 46 CFR 25.30-1, with new text to clarify the applicability of this subpart to recreational vessels with propulsion machinery only</ENT>
                        <ENT>No cost.</ENT>
                    </ROW>
                    <ROW EXPSTB="03" RUL="s">
                        <ENT I="21">
                            <E T="02">General Provisions</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00" RUL="s">
                        <ENT I="01">§ 25.30-5(a)</ENT>
                        <ENT>§ 175.305</ENT>
                        <ENT>Incorporate existing text from 46 CFR 25.30-5(a), with text edits to clarify approved equipment must be approved by the Commandant (CG-ENG-4). Removes reference to COMDTINST M16714.3 (Series), which has been cancelled</ENT>
                        <ENT>No cost, and a qualitative benefit from removing a COMDTINST that is no longer published. This change reduces confusion in reading the regulatory text.</ENT>
                    </ROW>
                    <ROW EXPSTB="03" RUL="s">
                        <ENT I="21">
                            <E T="02">Portable Fire Extinguishers and Semi-Portable Fire Extinguishing Systems</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">§ 25.30-5(b)</ENT>
                        <ENT>§ 175.310(a)</ENT>
                        <ENT>Incorporate existing text from 46 CFR 25.30-5(b)</ENT>
                        <ENT>No cost.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">§ 25.30-10(a)</ENT>
                        <ENT>§ 175.310(a)</ENT>
                        <ENT>Incorporate existing text from 46 CFR 25.30-10(a), with edits removing the requirement that the portable fire extinguishers be maintained, inspected, and recorded in accordance with NFPA 10. Add new text, extracted from relevant sections of NFPA 10, requiring that portable fire extinguishers must be accessible, have a good operating pressure, not be expired or previously used, and be maintained in “good and serviceable” working condition</ENT>
                        <ENT>No cost.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">§ 25.30-10(f)</ENT>
                        <ENT>§ 175.310(b)</ENT>
                        <ENT>Incorporate existing text from 46 CFR 25.30-10(f), with text edits for clarification</ENT>
                        <ENT>No cost.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">§ 25.30-10(g)</ENT>
                        <ENT>§ 175.310(c)</ENT>
                        <ENT>Incorporate existing text from 46 CFR 25.30-10(g)</ENT>
                        <ENT>No cost.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">§ 25.30-10(h)</ENT>
                        <ENT>§ 175.310(d)</ENT>
                        <ENT>Incorporate existing text from 46 CFR 25.30-10(h)(1)-25.30-10(h)(4), with edits changing the motorboat references to recreational vessel references</ENT>
                        <ENT>No cost.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">§ 25.30-10 (i)</ENT>
                        <ENT>§ 175.310(e)</ENT>
                        <ENT>Incorporate existing text from 46 CFR 25.30-10(i), with edits changing the motorboat references to recreational vessel references</ENT>
                        <ENT>No cost.</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">§ 25.30-10(j)</ENT>
                        <ENT>§ 175.310(f)</ENT>
                        <ENT>Adopt existing text from 46 CFR 25.30-10(j)</ENT>
                        <ENT>No cost.</ENT>
                    </ROW>
                    <ROW EXPSTB="03" RUL="s">
                        <ENT I="21">
                            <E T="02">Fixed Fire Extinguishing Systems</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">§ 25.30-15(a)</ENT>
                        <ENT>§ 175.315(a)</ENT>
                        <ENT>Incorporate existing text from 46 CFR 25.30-15(a) with text edits to clarify approved equipment must be approved by the Commandant (CG-ENG-4)</ENT>
                        <ENT>No cost.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">§ 25.30-15(b)</ENT>
                        <ENT>§ 175.315(b)</ENT>
                        <ENT>Incorporate existing text from 46 CFR 25.30-15(b)</ENT>
                        <ENT>No cost.</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">§ 25.30-15(c)</ENT>
                        <ENT>§ 175.315(c)</ENT>
                        <ENT>Incorporate existing text from 46 CFR 25.30-15(c) with edits to update references from NFPA 13 to the 46 CFR source</ENT>
                        <ENT>No cost.</ENT>
                    </ROW>
                    <ROW EXPSTB="03" RUL="s">
                        <ENT I="21">
                            <E T="02">Fire Extinguishing Equipment Required</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">§ 25.30-20(a)</ENT>
                        <ENT>§ 175.320(a)</ENT>
                        <ENT>Incorporate existing text from 46 CFR 25.30-20(a)(1) and 25.30-20(a)(2), with edits changing the motorboat references to recreational vessels not more than 65 feet</ENT>
                        <ENT>No cost.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Table 25.30-20(a)(1)</ENT>
                        <ENT>Table 1 to § 175.320(a)</ENT>
                        <ENT>Incorporate existing table 25.30-20(a)(1) from 46 CFR 25.30-20(a), with edits changing the table numbering for clarity</ENT>
                        <ENT>No cost.</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="58568"/>
                        <ENT I="01">Figure 25.30-20(a)(1)</ENT>
                        <ENT>Figure 1 to § 175.320(a)(2)</ENT>
                        <ENT>Incorporate existing figure 25.30-20(a)(1) from 46 CFR 25.30-20(a), with edits changing the figure numbering for clarity</ENT>
                        <ENT>No cost.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Figure 25.30-20(a)(2)</ENT>
                        <ENT>Figure 2 to § 175.320(a)(2)</ENT>
                        <ENT>Incorporate existing figure 25.30-20(a)(2) from 46 CFR 25.30-20(a), with edits changing the figure numbering for clarity</ENT>
                        <ENT>No cost.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">§ 25.30-20(c)</ENT>
                        <ENT>§ 175.320(b)</ENT>
                        <ENT>Incorporate existing text from 46 CFR 25.30-20(c)(1)-25.30-20(c)(4), with edits changing the motor vessels references to recreational vessels over 65 feet, and text edits for clarity</ENT>
                        <ENT>No cost.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Table 25.30-20(b)(1)</ENT>
                        <ENT>Table 1 to § 175.320(b)</ENT>
                        <ENT>Incorporate existing table 25.30-20(b)(1) from 46 CFR 25.30-20(b), with edits changing the table numbering for clarity</ENT>
                        <ENT>No cost.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">§ 25.30-20(c)</ENT>
                        <ENT>§ 175.320(b)</ENT>
                        <ENT>Incorporate existing text from 46 CFR 25.30-20(c), with edits changing the motor vessels references to recreational vessels over 65 feet</ENT>
                        <ENT>No cost.</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">§ 25.30-20(a)(3), § 25.30-20(c)(5)</ENT>
                        <ENT>§ 175.320(c)</ENT>
                        <ENT>Combine the existing text from 46 CFR 25.30-20(a)(3) and 25.30-20(c)(5) into a new section that clarifies table 1 to 46 CFR 175.320(a) and table 1 to 46 CFR 175.320(b) containing the minimum number of portable fire extinguishers needed on a vessel</ENT>
                        <ENT>No cost.</ENT>
                    </ROW>
                    <ROW EXPSTB="03" RUL="s">
                        <ENT I="21">
                            <E T="02">Location and Number of Portable Fire Extinguishers Required for Vessels Constructed prior to August 22, 2016</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00" RUL="s">
                        <ENT I="01">§ 25.30-80</ENT>
                        <ENT>§ 175.380</ENT>
                        <ENT>Incorporate existing text from 46 CFR subpart 25.30-80 with updated references to table 1 to 46 CFR 175.320(a) and table 1 to 46 CFR 175.320(b)</ENT>
                        <ENT>No cost.</ENT>
                    </ROW>
                    <ROW EXPSTB="03" RUL="s">
                        <ENT I="21">
                            <E T="02">Vessels Contracted prior to November 19, 1952</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00" RUL="s">
                        <ENT I="01">§ 25.30-90</ENT>
                        <ENT>§ 175.390</ENT>
                        <ENT>Incorporate existing text from 46 CFR 25.30-90 with updated references to the new 46 CFR 175 and text edits for clarity</ENT>
                        <ENT>No cost.</ENT>
                    </ROW>
                    <ROW EXPSTB="03" RUL="s">
                        <ENT I="21">
                            <E T="02">Edits to 46 CFR Part 25.30</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">§ 25.30-1</ENT>
                        <ENT/>
                        <ENT>Edit and reorganize paragraph for clarity</ENT>
                        <ENT>No cost.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">§ 25.30-1</ENT>
                        <ENT/>
                        <ENT>Remove applicability to non-commercial vessels</ENT>
                        <ENT>For recreational vessel owners and operators, there is a cost savings of 12 minutes per fire extinguisher per year on board each recreational vessel.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">Costs</HD>
                <P>The Coast Guard considered all potential costs of this final rule. We considered the possibility that the States, District of Columbia, and territorial jurisdictions may choose to update their statutes and regulations because of this final rule if they previously had changed their regulations to satisfy NFPA 10. However, based on a thorough search of the regulatory documents of the States, District of Columbia, and territories, the Coast Guard found no evidence of these jurisdictions changing their regulations to satisfy NFPA 10. Therefore, these changes will not incur any costs.</P>
                <HD SOURCE="HD3">Cost Savings</HD>
                <P>The primary savings of this final rule stem from alleviating the regulatory burden that the Fire Protection rule placed on the recreational vessel community. We tried to capture the potential aggregate scale of this regulatory burden reduction on the affected population of recreational vessel owners, but enforcement and compliance data is nonexistent. As an alternative, we provided an individual level estimate for the cost savings to the affected population of recreational vessel owners. We can offer this estimate because individual recreational vessel owners within the affected population must currently comply with the NFPA 10 requirements imposed by the Fire Protection rule.</P>
                <P>NFPA 10 has specific inspection requirements for both rechargeable and non-rechargeable portable fire extinguishers. Owners of vessels with non-rechargeable (disposable) fire extinguishers, commonly used in the recreational vessel community, are subject to a monthly visual inspection ensuring the portable fire extinguisher is available and still operational. They also must maintain records of their compliance by placing an initial in a logbook as confirmation of a visual inspection. Rechargeable portable fire extinguishers are not common in the 5-B size that is required for recreational boats and actively must be sought and bought from an industrial distributor.</P>
                <P>Rechargeable portable units of this size tend to be special purpose extinguishers such as carbon dioxide or clean agent extinguishers commonly used in areas such as server rooms, not on recreational boats, and come at a significantly higher price. Non-rechargeable or disposable portable units are intended for use by the public and are the primary type of fire extinguisher on recreational vessels. They are primarily marketed to the public because of their low operating and maintenance costs, low upfront cost, reliability as well as the ease of care, and wide accessibility to be purchased at retail stores. As a result, commercial vessel owners generally purchase rechargeable portable fire extinguishers, while recreational vessel owners purchase non-rechargeable units.</P>
                <P>
                    This rule replaces the required NFPA 10 monthly inspections and recordkeeping with a performance standard that vessel owners can meet in the manner least burdensome to each owner. Accordingly, we expect that this change will not impose any additional costs on recreational vessel owners. We estimate the savings to recreational boaters will stem from eliminating a recordkeeping burden. We estimate the recordkeeping takes 1 minute per month to complete for an annual total of 12 minutes per fire extinguisher.
                    <SU>23</SU>
                    <FTREF/>
                     It does 
                    <PRTPAGE P="58569"/>
                    not include the costs to the boater of traveling to the vessel when it is not in use. We did not estimate the travel costs because we do not have any data on the average travel time to their vessel when not in use. Additionally, we lack data on the number of months a vessel might be in use.
                </P>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         The value of a person's recreational time is dependent on a number of factors such as income, age, and employment status. Guidance for leisure time's value is available from the U.S. Department of Transportation Office of the Secretary memorandum on 
                        <E T="03">Revised Departmental Guidance on Valuation of Travel Time in Economic Analyses</E>
                          
                        <PRTPAGE/>
                        and may be found at 
                        <E T="03">https://www.transportation.gov/office-policy/transportation-policy/revised-departmental-guidance-valuation-travel-time-economic.</E>
                         With no data available on the affected population's income, the median income for the nation may be used as a proxy. This is a 12 minute reduction per fire extinguisher. We did not have the number of fire extinguishers per vessel. As a result, we did not quantify the value of time saved by this rule.
                    </P>
                </FTNT>
                <P>
                    Data is not available on how many recreational vessel owners have complied with the current NFPA 10 requirements since 2016 because the Coast Guard does not track that information. We also have notified the States and territories about the NBSAC Resolution 2016-96-02. As a result, we acknowledge the nonzero probability that a given vessel owner may be complying. Therefore, this final rule may reduce the regulatory burden of the recordkeeping requirement for some recreational vessel owners. We do not have enough information to estimate the aggregate scale of this reduction. However, we provide an individual level estimate for the cost savings to the affected population of recreational vessel owners legally required to comply. We estimate 12 minutes per year per portable fire extinguisher (1 minute per month) as the average individual level cost savings.
                    <SU>24</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         This estimate comports with estimates found in OMB collections: 2105-0529, 1625-0079 and 1625-0063 as adjusted for complexity of the task.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Benefits</HD>
                <P>By moving from a prescriptive requirement to a performance standard, this rule maintains safety preparedness standards while allowing recreational vessel owners and operators to meet the safety requirements in the way best suited for each owner/operator. By shifting the recreational vessel fire extinguishing equipment requirements from 46 CFR part 25, subpart 25.30 to 33 CFR part 175, subpart E, this rule will create a clear distinction between fire extinguishing equipment regulations intended for commercial vessels and those intended for recreational vessels. Additionally, we removed references to the outdated COMDTINST M16714.3, making the regulatory text easier to read and understand.</P>
                <HD SOURCE="HD3">Alternatives</HD>
                <P>The final rule (the preferred alternative) will move the fire extinguishing equipment requirements for recreational vessels from 46 CFR part 25, subpart 25.30 to 33 CFR part 175, new subpart E. This will create a clear distinction between fire extinguishing equipment regulations intended for commercial vessels and those intended for recreational vessels. The final rule will remove all the NFPA 10 inspection, maintenance and recordkeeping requirements for recreational vessels. This change will result in cost savings in the form of time savings to recreational vessel owners of 12 minutes per year per fire extinguisher on recreational vessels, plus travel time when the vessel is not in use. It re-organizes the regulatory text to separate recreational vessel fire protection regulations from commercial vessel regulations and to consolidate recreational vessel fire extinguishing equipment requirements into one subchapter. Lastly, the final rule follows the NBSAC recommendation.</P>
                <P>Within the Coast Guard's development of the final rule, we considered alternatives to determine if any of them could accomplish the stated objectives. Among these alternatives were the following:</P>
                <HD SOURCE="HD3">Alternative 1: No-Action</HD>
                <P>Under this alternative, recreational vessel fire protection rules would remain in 46 CFR subpart 25.30, and NFPA 10 would continue to apply to recreational vessels. The Coast Guard did not select this alternative because it maintains an unnecessary regulatory burden. It would also continue a situation that lacks regulatory clarity and creates confusion.</P>
                <HD SOURCE="HD3">Alternative 2: Policy Over Regulation</HD>
                <P>This alternative would create a new Coast Guard policy based on NBSAC's recommendation to end the applicability of NFPA 10 to motorized recreational vessels and outline fire extinguishing equipment standards. It would impose no new costs and would have no cost savings. The Coast Guard did not select this option because States adopt Coast Guard regulations, not Coast Guard policy recommendations. This alternative would not amend the current CFR and may cause confusion depending on the nature of implementation.</P>
                <HD SOURCE="HD3">Alternative 3: Add Exemption From NFPA 10 Requirements</HD>
                <P>Under this alternative, the Coast Guard would have added language to 46 CFR part 25, subpart 25.30 explicitly stating that NFPA 10 does not apply to recreational vessels. However, this would remove fire equipment applicability for motorized recreational vessels owners. This change would also result in the lack of regulatory requirements for recreational vessels. It would impose no new costs. The Coast Guard did not select this option because this alternative may create a safety hazard for motorized recreational vessel owners.</P>
                <HD SOURCE="HD2">B. Small Entities</HD>
                <P>Under the Regulatory Flexibility Act, 5 U.S.C. 601-612, we have considered whether this rule would have a significant economic impact on a substantial number of small entities. 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.</P>
                <P>The final rule alleviates the regulatory burden placed on 11,052,684 recreational vessels and will move fire extinguishing equipment requirements for recreational vessels from 46 CFR part 25, subpart 25.30 to a new subpart E (Fire Protection Equipment) in 33 CFR part 175. The Coast Guard's economic analysis concluded that it expects these changes would not impose additional costs on any of the recreational vessels that comprise the affected population in this final rule because this rule replaces the required NFPA 10 monthly inspections with a performance standard that vessel owners can meet in the manner least burdensome to each owner. Additionally, this rule eliminates regulatory burdens from the NFPA 10 recordkeeping requirements, resulting in an estimated 12 minutes of time savings per recreational vessel owner per fire extinguisher, plus travel time when the vessel was not in use.</P>
                <P>Therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that this final rule will not have a significant economic impact on a substantial number of small entities.</P>
                <HD SOURCE="HD2">C. Assistance for Small Entities</HD>
                <P>
                    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121, we offer to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking. 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.
                    <PRTPAGE P="58570"/>
                </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).</P>
                <HD SOURCE="HD2">D. Collection of Information</HD>
                <P>This final rule will call for no new collection of information under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3520. As defined in 5 CFR 1320.3(c), “collection of information” comprises reporting, recordkeeping, monitoring, posting, labeling, and other similar actions.</P>
                <HD SOURCE="HD2">E. Federalism</HD>
                <P>A rule has implications for federalism under Executive Order 13132 (Federalism) if it has a substantial direct effect on States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this final rule under Executive Order 13132 and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132. Our analysis follows.</P>
                <P>It is well settled that States may not regulate in categories reserved for regulation by the Coast Guard. The Coast Guard regulates recreational vessel safety, including firefighting equipment, under the authority contained in 46 U.S.C. 4302. Chapter 43 of 46 U.S.C. contains an express preemption provision for recreational vessel safety standards. Under 46 U.S.C. 4306, a State or political subdivision of a State may not establish, continue in effect, or enforce a law or regulation establishing a recreational vessel or associated equipment performance or other safety standard, or impose a requirement for associated equipment unless: (1) The standard is identical to a Coast Guard regulation prescribed under 46 U.S.C. 4302; (2) the Coast Guard specifically provides an exemption under 46 U.S.C. 4305; or (3) the State standard regulates marine safety articles carried or used to address a hazardous condition or circumstance unique to that State (as long as the Coast Guard does not disapprove). This final rule establishes minimum requirements, under 46 U.S.C. 4302, for fire extinguishing equipment for recreational vessels, and, therefore, the States may not issue regulations that differ from Coast Guard regulations within the categories of safety standards or equipment for recreational vessels, except in the limited circumstances identified above. Therefore, this final rule is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.</P>
                <HD SOURCE="HD2">F. Unfunded Mandates</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. Although this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.</P>
                <HD SOURCE="HD2">G. Taking of Private Property</HD>
                <P>This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630 (Governmental Actions and Interference with Constitutionally Protected Property Rights).</P>
                <HD SOURCE="HD2">H. Civil Justice Reform</HD>
                <P>This final rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988 (Civil Justice Reform) to minimize litigation, eliminate ambiguity, and reduce burden.</P>
                <HD SOURCE="HD2">I. Protection of Children</HD>
                <P>We have analyzed this final rule under Executive Order 13045 (Protection of Children from Environmental Health Risks and Safety Risks). This rule is not an economically significant rule and will not create an environmental risk to health or risk to safety that might disproportionately affect children.</P>
                <HD SOURCE="HD2">J. Indian Tribal Governments</HD>
                <P>This final rule does not have tribal implications under Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments), because it will 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">K. Energy Effects</HD>
                <P>We have analyzed this rule under Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use). We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy.</P>
                <HD SOURCE="HD2">L. Technical Standards</HD>
                <P>The National Technology Transfer and Advancement Act, codified as a note to 15 U.S.C. 272, directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through OMB, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (for example, specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.</P>
                <P>This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.</P>
                <HD SOURCE="HD2">M. Environment</HD>
                <P>
                    We have analyzed this final rule under DHS Management 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 made a determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. 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>
                <P>
                    This rule is categorically excluded under paragraphs L52, L54, and L57 of Table 1 in Appendix A of DHS Directive 023-01 (series). The categorical exclusion (CATEX) L52 pertains to regulations concerning vessel operation safety standards; CATEX L54 pertains to regulations that are editorial or procedural, such as those updating addresses or establishing application procedures; and CATEX 57 pertains to 
                    <PRTPAGE P="58571"/>
                    regulations concerning manning, documentation, admeasurements, inspection, and equipping of vessels.
                </P>
                <P>This final rule will update Coast Guard regulations pertaining to fire extinguishing requirements and the associated standards used by recreational vessels.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects</HD>
                    <CFR>
                        <E T="03">33 CFR Part 1</E>
                    </CFR>
                    <P>Administrative practice and procedure, Authority delegations (Government agencies), Freedom of information, Penalties.</P>
                    <CFR>
                        <E T="03">33 CFR Part 175</E>
                    </CFR>
                    <P>Fire prevention, Marine safety.</P>
                    <CFR>
                        <E T="03">46 CFR Part 25</E>
                    </CFR>
                    <P>Fire prevention, Marine safety, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <P>For the reasons discussed in the preamble, the Coast Guard amends 33 CFR parts 1 and 175 and 46 CFR part 25 as follows:</P>
                <HD SOURCE="HD1">Title 33—Navigation and Navigable Waters</HD>
                <PART>
                    <HD SOURCE="HED">PART 1—GENERAL PROVISIONS</HD>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart 1.08—Written Warning by Coast Guard Boarding Officers</HD>
                    </SUBPART>
                </PART>
                <REGTEXT TITLE="33" PART="1">
                    <AMDPAR>1. The authority citation for part 1, subpart 1.08, continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 14 U.S.C. 503; 49 CFR 1.46(b).</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="33" PART="1">
                    <AMDPAR>2. In § 1.08-1, revise paragraph (a)(8) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 1.08-1</SECTNO>
                        <SUBJECT> Applicability.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>(8) 46 CFR subpart 25.30, Fire Extinguishing Equipment and 33 CFR part 175, subpart E, Fire Protection Equipment;</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 175—EQUIPMENT REQUIREMENTS</HD>
                </PART>
                <REGTEXT TITLE="33" PART="175">
                    <AMDPAR>3. The authority citation for part 175 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 46 U.S.C. 4302; Department of Homeland Security Delegation No. 0170.1.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="33" PART="175">
                    <AMDPAR>4. In § 175.3, add in alphabetic order a definition for “Model year” to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 175.3</SECTNO>
                        <SUBJECT> Definitions.</SUBJECT>
                        <STARS/>
                        <P>
                            <E T="03">Model year</E>
                             means the period beginning June 1 of a year and ending on July 31 of the following year and being designated by the year in which it ends.
                        </P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="33" PART="175">
                    <AMDPAR>5. Add subpart E, consisting of §§ 175.301 through 175.390, to read as follows:</AMDPAR>
                    <CONTENTS>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart E—Fire Protection Equipment</HD>
                            <SECHD>Sec.</SECHD>
                            <SECTNO>175.301 </SECTNO>
                            <SUBJECT>Applicability.</SUBJECT>
                            <SECTNO>175.305 </SECTNO>
                            <SUBJECT>General provisions.</SUBJECT>
                            <SECTNO>175.310 </SECTNO>
                            <SUBJECT>Portable fire extinguishers and semi-portable fire extinguishing systems.</SUBJECT>
                            <SECTNO>175.315 </SECTNO>
                            <SUBJECT>Fixed fire extinguishing systems.</SUBJECT>
                            <SECTNO>175.320 </SECTNO>
                            <SUBJECT>Fire extinguishing equipment required.</SUBJECT>
                            <SECTNO>175.380 </SECTNO>
                            <SUBJECT>Condition and number of fire extinguishers required for recreational vessels built model year 2017 or earlier.</SUBJECT>
                            <SECTNO>175.390 </SECTNO>
                            <SUBJECT>Condition and number of fire extinguishers required for recreational vessels built before model year 1953.</SUBJECT>
                        </SUBPART>
                    </CONTENTS>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart E—Fire Protection Equipment</HD>
                        <SECTION>
                            <SECTNO>§ 175.301</SECTNO>
                            <SUBJECT> Applicability.</SUBJECT>
                            <P>(a) This subpart applies to recreational vessels that are propelled or controlled by propulsion machinery.</P>
                            <P>(b) Recreational vessels constructed prior to August 22, 2016, will be deemed built before model year 2017 and must meet the requirements of 33 CFR 175.380.</P>
                            <P>(c) Recreational vessels constructed prior to November 19, 1952, will be deemed built before model year 1953 and must meet the requirements of 33 CFR 175.390.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 175.305</SECTNO>
                            <SUBJECT> General provisions.</SUBJECT>
                            <P>
                                Where fire extinguishing equipment in this subpart is required to be of an approved type, such equipment must be approved as provided in 46 CFR chapter I, subchapter Q. A listing of current and formerly approved equipment and materials may be found on the internet at: 
                                <E T="03">https://cgmix.uscg.mil/equipment.</E>
                                 Each OCMI may be contacted for information concerning approved equipment.
                            </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 175.310</SECTNO>
                            <SUBJECT> Portable fire extinguishers and semi-portable fire extinguishing systems.</SUBJECT>
                            <P>(a) All portable and semi-portable fire extinguishers must—</P>
                            <P>(1) Be on board and readily accessible;</P>
                            <P>(2) Be of an approved type;</P>
                            <P>(3) Not be expired or appear to have been previously used; and</P>
                            <P>(4) Be maintained in good and serviceable working condition, meaning:</P>
                            <P>(i) If the extinguisher has a pressure gauge reading or indicator it must be in the operable range or position;</P>
                            <P>(ii) The lock pin is firmly in place;</P>
                            <P>(iii) The discharge nozzle is clean and free of obstruction; and</P>
                            <P>(iv) The extinguisher does not show visible signs of significant corrosion or damage.</P>
                            <P>(b) Vaporizing-liquid type fire extinguishers containing carbon tetrachloride, chlorobromomethane, or other toxic vaporizing liquids, are not acceptable as equipment required by this subpart.</P>
                            <P>(c) Portable or semi-portable extinguishers that are required by their name plates to be protected from freezing must not be located where freezing temperatures may be expected.</P>
                            <P>(d) The use of dry chemical stored pressure fire extinguishers not fitted with pressure gauges or indicating devices, manufactured prior to January 1, 1965, is permitted on board recreational vessels if such extinguishers are maintained in good and serviceable condition. The following maintenance and inspections are required for such extinguishers:</P>
                            <P>(1) When the date on the inspection record tag on the extinguishers shows that 6 months have elapsed since the last weight check ashore, then such extinguishers are no longer accepted as meeting required maintenance conditions until they are reweighed ashore, found to be in a serviceable condition, and within required weight conditions.</P>
                            <P>
                                (2) If the weight of the container is 
                                <FR>1/4</FR>
                                 ounce less than that stamped on the container, it must be serviced.
                            </P>
                            <P>(3) If the outer seal or seals (which indicate tampering or use when broken) are not intact, the boarding officer or marine inspector will inspect such extinguishers to see that the frangible disc in the neck of the container is intact; and, if such disc is not intact, the container must be serviced.</P>
                            <P>(4) If there is evidence of damage, use, or leakage, such as dry chemical powder observed in the nozzle or elsewhere on the extinguisher, the extinguisher must be serviced or replaced.</P>
                            <P>(e) Dry chemical extinguishers, stored pressure extinguishers, and fire extinguishers without pressure gauges or indicating devices, manufactured after January 1, 1965, cannot be labeled with the marine type label described in 46 CFR 162.028-4. These extinguishers may be carried onboard recreational vessels as excess equipment, subject to paragraphs (a) and (b) of this section.</P>
                            <P>(f) Semi-portable extinguishers must be fitted with a suitable hose and nozzle, or other practicable means, so that all portions of the space concerned may be covered.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 175.315</SECTNO>
                            <SUBJECT> Fixed fire extinguishing systems.</SUBJECT>
                            <P>
                                (a) A fixed fire extinguishing system must be of a type approved by the Coast Guard under 46 CFR part 162.
                                <PRTPAGE P="58572"/>
                            </P>
                            <P>(b) A carbon dioxide system must be designed and installed in accordance with 46 CFR part 76, subpart 76.15.</P>
                            <P>(c) An automatic sprinkler system must be designed and installed in accordance with 46 CFR 25.30-15(c).</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 175.320 </SECTNO>
                            <SUBJECT>Fire extinguishing equipment required.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Recreational vessels 65 feet or less in length.</E>
                                 (1) A recreational vessel 65 feet or less in length must carry at least the minimum number of portable fire extinguishers set forth in table 1 to § 175.320(a)(1). A vessel less than 26 feet in length, propelled by an outboard motor, is not required to carry portable fire extinguishers if the construction of the vessel will not permit the entrapment of explosive or flammable gases or vapors.
                            </P>
                            <GPOTABLE COLS="03" OPTS="L2,i1" CDEF="s100,15,15">
                                <TTITLE>
                                    Table 1 to § 175.320(
                                    <E T="01">a</E>
                                    )(
                                    <E T="01">1</E>
                                    )
                                </TTITLE>
                                <BOXHD>
                                    <CHED H="1">Length (feet)</CHED>
                                    <CHED H="1">
                                        Minimum number of 5-B portable 
                                        <LI>
                                            fire extinguishers required 
                                            <SU>1</SU>
                                        </LI>
                                    </CHED>
                                    <CHED H="2">
                                        If no fixed fire
                                        <LI>extinguishing</LI>
                                        <LI>system in</LI>
                                        <LI>machinery space</LI>
                                    </CHED>
                                    <CHED H="2">
                                        If fixed fire
                                        <LI>extinguishing</LI>
                                        <LI>system in</LI>
                                        <LI>machinery space</LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">Under 16</ENT>
                                    <ENT>1</ENT>
                                    <ENT>0</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">16 or more, but less than 26</ENT>
                                    <ENT>1</ENT>
                                    <ENT>0</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">26 or more, but less than 40</ENT>
                                    <ENT>2</ENT>
                                    <ENT>1</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">40 or more, but not more than 65</ENT>
                                    <ENT>3</ENT>
                                    <ENT>2</ENT>
                                </ROW>
                                <TNOTE>
                                    <SU>1</SU>
                                     One 20-B portable fire extinguisher may be substituted for two 5-B portable fire extinguishers.
                                </TNOTE>
                            </GPOTABLE>
                            <P>(2) Figure 1 to § 175.320(a)(2) illustrates the conditions, identified by table 2 to § 175.320(a)(2), under which fire extinguishers are required to be carried on board. Figure 2 to § 175.320(a)(2) illustrates conditions, identified by table 3 to § 175.320(a)(2), that do not, in themselves, require that fire extinguishers be carried.</P>
                            <GPH SPAN="3" DEEP="72">
                                <GID>ER22OC21.000</GID>
                            </GPH>
                            <GPOTABLE COLS="02" OPTS="L2,i1" CDEF="xs80,r75">
                                <TTITLE>
                                    Table 2 to § 175.320(
                                    <E T="01">a</E>
                                    )(
                                    <E T="01">2</E>
                                    )
                                </TTITLE>
                                <BOXHD>
                                    <CHED H="1">
                                        Location identified
                                        <LI>in Figure</LI>
                                        <LI>1 to § 175.320(a)(2)</LI>
                                    </CHED>
                                    <CHED H="1">Condition requiring fire extinguishers</CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">1</ENT>
                                    <ENT>Closed compartment under thwarts and seats wherein portable fuel tanks may be stored.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">2</ENT>
                                    <ENT>Double bottoms not sealed to the hull or which are not completely filled with flotation material.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">3 </ENT>
                                    <ENT>Closed living spaces.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">4</ENT>
                                    <ENT>Closed stowage compartments in which combustible or flammable materials are stowed.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">5 </ENT>
                                    <ENT>Permanently installed fuel tanks.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <GPH SPAN="3" DEEP="74">
                                <GID>ER22OC21.001</GID>
                            </GPH>
                            <PRTPAGE P="58573"/>
                            <GPOTABLE COLS="02" OPTS="L2,i1" CDEF="xs80,r75">
                                <TTITLE>
                                    Table 3 to § 175.320(
                                    <E T="01">a</E>
                                    )(
                                    <E T="01">2</E>
                                    )
                                </TTITLE>
                                <BOXHD>
                                    <CHED H="1">
                                        Location identified in Figure 2
                                        <LI>to § 175.320(a)(2)</LI>
                                    </CHED>
                                    <CHED H="1">Condition requiring fire extinguishers</CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">1 </ENT>
                                    <ENT>Bait wells.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">2 </ENT>
                                    <ENT>Glove compartments.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">3 </ENT>
                                    <ENT>Buoyant flotation material.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">4 </ENT>
                                    <ENT>Open slatted flooring.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">5 </ENT>
                                    <ENT>Ice chests.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <P>
                                (b) 
                                <E T="03">Recreational vessels more than 65 feet in length.</E>
                                 (1) A recreational vessel more than 65 feet in length must carry at least the minimum number of portable fire extinguishers specified for its tonnage as set forth in table 4 to § 175.320(b)(1).
                            </P>
                            <GPOTABLE COLS="03" OPTS="L2,i1" CDEF="s10,10,13">
                                <TTITLE>
                                    Table 4 to § 175.320(
                                    <E T="01">b</E>
                                    )(
                                    <E T="01">1</E>
                                    )
                                </TTITLE>
                                <BOXHD>
                                    <CHED H="1">Gross tonnage—</CHED>
                                    <CHED H="2">More than</CHED>
                                    <CHED H="2">Not more than</CHED>
                                    <CHED H="1">
                                        Minimum 
                                        <LI>number of </LI>
                                        <LI>20-B portable </LI>
                                        <LI>fire </LI>
                                        <LI>extinguishers</LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="22"> </ENT>
                                    <ENT>50</ENT>
                                    <ENT>1</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">50</ENT>
                                    <ENT>100</ENT>
                                    <ENT>2</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">100</ENT>
                                    <ENT>500</ENT>
                                    <ENT>3</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">500</ENT>
                                    <ENT>1,000</ENT>
                                    <ENT>6</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">1,000</ENT>
                                    <ENT/>
                                    <ENT>8</ENT>
                                </ROW>
                            </GPOTABLE>
                            <P>(2) In addition to the portable fire extinguishers required by table 4 to § 175.320(b)(1), the following fire extinguishing equipment must be fitted in the machinery space:</P>
                            <P>(i) One 20-B fire extinguisher must be carried for each 1,000 brake horsepower of the main engines or fraction. However, not more than six such extinguishers are required to be carried.</P>
                            <P>(ii) On recreational vessels of more than 300 gross tons, either one 160-B semi-portable fire extinguishing system must be fitted, or alternatively, a fixed fire extinguishing system must be fitted in the machinery space.</P>
                            <P>(3) The frame or support of each 160-B semi-portable fire extinguisher required by paragraph (b)(2)(ii) of this section must be welded or otherwise permanently attached to a bulkhead or deck.</P>
                            <P>(4) If an approved semi-portable fire extinguisher has wheels, it must be securely stowed when not in use to prevent it from rolling out of control under heavy sea conditions.</P>
                            <P>
                                (c) 
                                <E T="03">Extinguishers with larger numerical ratings or multiple letter designations.</E>
                                 Extinguishers with larger numerical ratings or multiple letter designations may be used to meet the requirements of table 1 to § 175.320(a)(1) and table 4 to § 175.320(b)(1).
                            </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 175.380 </SECTNO>
                            <SUBJECT>Condition and number of fire extinguishers required for recreational vessels built model year 2017 or earlier.</SUBJECT>
                            <P>Recreational vessels with a model year between 1953 and 2017 must meet the following requirements:</P>
                            <P>(a) Previously installed extinguishers with extinguishing capacities that are less than what is required in table 1 to § 175.320(a)(1) or table 2 to § 175.320(b)(1) need not be replaced but must be maintained in good condition.</P>
                            <P>(b) All extinguishers installed after August 22, 2016, must meet the applicable requirements in §§ 175.305 through 175.320.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 175.390 </SECTNO>
                            <SUBJECT>Condition and number of fire extinguishers required for recreational vessels built before model year 1953.</SUBJECT>
                            <P>A recreational vessel built before model year 1953 must meet the applicable number and general type of equipment provisions of §§ 175.305 through 175.320. Existing items of equipment and installations previously approved but not meeting the applicable requirements for type approval may be continued in service provided they are in good condition. All new installations and replacements must meet the requirements of §§ 175.305 through 175.320.</P>
                        </SECTION>
                    </SUBPART>
                </REGTEXT>
                <HD SOURCE="HD1">Title 46—Shipping</HD>
                <PART>
                    <HD SOURCE="HED">PART 25—REQUIREMENTS</HD>
                </PART>
                <REGTEXT TITLE="46" PART="25">
                    <AMDPAR>6. The authority citation for part 25 is revised to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>33 U.S.C. 1903(b); 46 U.S.C. 2103, 3306, 4102, 4302; Department of Homeland Security Delegation No. 00170.1, Revision No. 01.2, paragraphs (II) (77), (92)(a), and 92(b).</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="46" PART="25">
                    <AMDPAR>7. Revise § 25.30-1 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 25.30-1 </SECTNO>
                        <SUBJECT>Applicability.</SUBJECT>
                        <P>(a) This subpart applies to all vessels contracted for on or after August 22, 2016, except for recreational vessels as defined in 33 CFR 175.3, which are governed by fire safety equipment requirements at 33 CFR part 175, subpart E.</P>
                        <P>(b) All vessels contracted for before August 22, 2016, and after November 19, 1952, except recreational vessels as defined in 33 CFR 175.3, must meet the requirements of 46 CFR 25.30-80.</P>
                        <P>(c) All vessels, contracted for before November 19, 1952, except recreational vessels as defined in 33 CFR 175.3, must meet the requirements of 46 CFR 25.30-90.</P>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <DATED>Dated: October 12, 2021.</DATED>
                    <NAME>J.W. Mauger,</NAME>
                    <TITLE>Rear Admiral, U.S. Coast Guard, Assistant Commandant for Prevention Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-22578 Filed 10-21-21; 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 100</CFR>
                <DEPDOC>[Docket No. USCG-2021-0697]</DEPDOC>
                <RIN>RIN 1625-AA08</RIN>
                <SUBJECT>Special Local Regulation; Sacramento Ironman Triathlon; American River and Sacramento River, Sacramento, CA</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 special local regulation for navigable waters on the Sacramento River. The special local regulation is needed to protect personnel, vessels, and the marine environment from potential hazards created by the Sacramento Ironman Triathlon marine event. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Sector San Francisco.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective on October 24, 2021 from 6 a.m. to 10 a.m.</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-2021-0697 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 about this rule, call or email Lieutenant Anthony I. Solares, U.S. Coast Guard District 11, Sector San Francisco, at 415-399-3585, 
                        <E T="03">SFWaterways@uscg.mil</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <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">COTP Captain of the Port</FP>
                    <FP SOURCE="FP-1">PATCOM Patrol Commander</FP>
                    <FP SOURCE="FP-1">U.S.C. United States Code</FP>
                </EXTRACT>
                <HD SOURCE="HD1">II. Background, Purpose, and Legal Basis</HD>
                <P>
                    The Coast Guard is issuing this temporary rule without prior notice and 
                    <PRTPAGE P="58574"/>
                    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 regulation by October 24, 2021 and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing this 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 public interest because immediate action is needed to ensure the safety of the participants and vessels during the Sacramento Ironman Triathlon on October 24, 2021.
                </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 (previously 33 U.S.C. 1231). The Captain of the Port Sector San Francisco (COTP) has determined that potential hazards associated with Sacramento Ironman Triathlon on October 24, 2021, will be a safety concern from Township 9 Park to the Sacramento River at Tower Bridge for four hours. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the special local regulation while the event is taking place.</P>
                <HD SOURCE="HD1">IV. Discussion of the Rule</HD>
                <P>This rule establishes a special local regulation starting in the American River from Township 9 Park to the Sacramento River at Tower Bridge. The safety zone will be in effect on October 24, 2021 from 6 a.m. to 10 a.m. The duration of the zone is intended to protect participants, and the marine environment in these navigable waters while the Sacramento Ironman Triathlon is taking place. No vessel or person will be permitted to enter the regulated area 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. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. 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), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.</P>
                <P>This regulatory action determination is based on the size, location, duration, and the time-of-day of the special local regulation. This special local regulation would impact a small designated area of the American River and Sacramento River for a short duration and vessel traffic will be able to transit after the time of the event. Moreover, the Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek 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 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>When the special local regulation is in effect, vessel traffic can pass safely around the regulated area. The maritime public will be advised in advance of this special local regulation via Broadcast Notice to Mariners.</P>
                <P>
                    If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see 
                    <E T="02">ADDRESSES</E>
                    ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.
                </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. 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 will 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.
                </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, 
                    <PRTPAGE P="58575"/>
                    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 special local regulation lasting only 4 hours that will prohibit entry within a 2 mile segment of the American River and Sacramento River. It is categorically excluded from further review under paragraph [L61] of 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 100</HD>
                    <P>Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.</P>
                </LSTSUB>
                <P>For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 100—SAFETY OF LIFE ON NAVIGABLE WATERS</HD>
                </PART>
                <REGTEXT TITLE="33" PART="100">
                    <AMDPAR>1. The authority citation for Part 100 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>46 U.S.C. 70041; 33 CFR 1.05-1.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="33" PART="100">
                    <AMDPAR>2. Add § 100.T1199-0697 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 100.T1199-0697 </SECTNO>
                        <SUBJECT>Special Local Regulation; Sacramento Ironman Triathlon; American River and Sacramento River, Sacramento, CA</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Regulated area.</E>
                             The regulations in this section apply to the following area: All waters of the American River and Sacramento River from Township 9 Park to Tower Bridge.
                        </P>
                        <P>
                            (b) 
                            <E T="03">Regulations.</E>
                             (1) All non-participants are prohibited from entering, transiting through, anchoring in, or remaining within the regulated area described in paragraph (a) of this section unless authorized by the Captain of the Port Sector San Francisco or their designated representative.
                        </P>
                        <P>(2) To seek permission to enter, contact the COTP or the COTP's representative by VHF Channel 69 or phone at 1-415-399-3547. Those in the regulated area must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.</P>
                        <P>(3) The COTP will provide notice of the regulated area through advanced notice via broadcast notice to mariners.</P>
                        <P>
                            (c) 
                            <E T="03">Enforcement period.</E>
                             This section will be enforced on October 24, 2021, from 6 a.m. to 10 a.m.
                        </P>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <DATED>Dated: October 15, 2021.</DATED>
                    <NAME>Taylor Q. Lam,</NAME>
                    <TITLE>Captain, U.S. Coast Guard, Captain of the Port, San Francisco.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23026 Filed 10-21-21; 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 100</CFR>
                <DEPDOC>[Docket No. USCG-2021-0761]</DEPDOC>
                <RIN>RIN 1625-AA08</RIN>
                <SUBJECT>Special Local Regulations; Perrysburg Regatta, Maumee River, Toledo, OH</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 will enforce a special local regulation for the Perrysburg Regatta from 7:30 a.m. through 3:30 p.m. on October 23, 2021 to provide for the safety of life on navigable waterways during this event. Our regulation for marine events within the Ninth Coast Guard District identifies the regulated area for this event in Toledo, OH. During the enforcement period, the operator of any vessel in the regulated area 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>This regulation will be enforced from 7:30 a.m. through 3:30 p.m. on October 23, 2021.</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-2021-0761 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 MST3 John Angotti, Waterways Department, Marine Safety Unit Toledo, Coast Guard; telephone (419) 418-6056, email 
                        <E T="03">john.t.angotti@uscg.mil.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <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 we must establish this special local regulation by October 23, 2021. Delaying the effective date of this regulation for a comment period to run would be contrary to the public interest and impractical because it would inhibit the Coast Guard's ability to protect spectators and vessels from the potential safety hazards associated with a marine regatta.</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 regulation would be contrary to the rule's objectives of protecting the safety of the public and property on the navigable waters in the vicinity of the regatta.
                </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 (previously 33 U.S.C. 1231). The Captain of the Port Detroit (COTP) has determined that potential hazards associated with the Perrysburg Regatta starting October 23, 2021, would be a safety concern for anyone navigating within the Maumee River, Toledo, OH.</P>
                <HD SOURCE="HD1">IV. Discussion of the Rule</HD>
                <P>
                    This rule establishes a temporary special local regulation from 7:30 a.m. 
                    <PRTPAGE P="58576"/>
                    through 3:30 p.m. on October 23, 2021. In light of the aforementioned hazards, the COTP has determined that a special local regulation is necessary to protect spectators, vessels, and participants. The special local regulation will encompass the following waterway: All waters of the Maumee River, Toledo OH between 200 feet off of the left descending bank and between the following two points: The first point is drawn from position 41°39′45.9″ N, 083°30′37.9″ W (NAD 83); the second point, to the south, is drawn from position 41°38′06.4″ N, 083°31′60.0″ W (NAD 83). During the period of enforcement, no vessels may enter, transit through, or anchor within the regulated area without the permission of the COTP or an on-scene representative. The COTP or a designated on-scene representative will notify the public of the enforcement of this rule by all appropriate means, including a Broadcast Notice to Mariners.
                </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, duration, and time-of-day of the special local regulation. Vessel traffic will be able to safely transit around this regulated area, which would impact a small designated area of the Maumee River for 6 hours in an area where vessel traffic is normally low. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek 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 area 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 special local regulation lasts 6 hours and will limit entry within the navigable waters of the Maumee River, Toledo, OH. 200 feet off of the left descending bank and between the following two points: The first point is drawn from position 41°39′45.9″ N, 083°30′37.9″ W (NAD 83); the second point, to the south, is drawn from position 41°38′06.4″ N, 083°31′60.0″ W (NAD 83). It is categorically excluded from further review under paragraph L[61] 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 
                    <PRTPAGE P="58577"/>
                    jeopardizing the safety or security of people, places or vessels.
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 33 CFR Part 100</HD>
                    <P>Marine safety, Navigation (water), Reporting and recordkeeping requirements, waterways, Security measures.</P>
                </LSTSUB>
                <P>For the reasons discussed in the preamble, the Coast Guard amends 33 CFR 100 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 100—SPECIAL LOCAL REGULATIONS; PERRYSBURG REGATTA, TOLEDO, OH</HD>
                </PART>
                <REGTEXT TITLE="33" PART="100">
                    <AMDPAR>1. The authority citation for part 100 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 46 U.S.C.70041; 33 CFR 1.05-1.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="33" PART="100">
                    <AMDPAR>2. Add § 100.T05-911 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 100.T05-911</SECTNO>
                        <SUBJECT> Special Local Regulations; Perrysburg Regatta, Maumee River, Toledo, OH</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Location.</E>
                             This special local regulation lasts 6 hours and will limit entry within the navigable waters of the Maumee River, Toledo, OH. 200 feet off of the left descending bank and between the following two points: The first point is drawn from position 41°39′45.9″ N, 083°30′37.9″ W (NAD 83); the second point, to the south, is drawn from position 41°38′06.4″ N, 083°31′60.0″ W (NAD 83).
                        </P>
                        <P>
                            (b) 
                            <E T="03">Enforcement period.</E>
                             The regulation will be enforced from 7:30 a.m. through 3:30 p.m. on October 23, 2021. The Captain of the Port Detroit will announce specific enforcement periods by Broadcast Notice to Mariners (BNM).
                        </P>
                        <P>
                            (c) 
                            <E T="03">Regulations.</E>
                             (1) In accordance with the general regulations in § 100.911(b), no vessel may enter, transit through, or anchor within the regulated area without the permission of the COTP or a designated on-scene representative.
                        </P>
                        <P>(2) Vessel operators desiring to enter or operate within the regulated area shall contact the Coast Guard Patrol Commander to obtain permission to do so. Vessel operators given permission to enter or operate within the regulated area must comply with all directions given to them by the Coast Guard Patrol Commander.</P>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <DATED>Dated: October 18, 2021.</DATED>
                    <NAME>Brad W. Kelly,</NAME>
                    <TITLE>Captain, U.S. Coast Guard, Captain of the Port Detroit.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23121 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9110-04-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 52</CFR>
                <DEPDOC>[EPA-R05-OAR-2021-0256; FRL-8692-02-R5]</DEPDOC>
                <SUBJECT>
                    Air Plan Approval; Wisconsin; Attainment Plan for the Rhinelander SO
                    <E T="0735">2</E>
                     Nonattainment Area
                </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 the State Implementation Plan (SIP) revision submitted by Wisconsin on March 29, 2021, which amends a SIP submission previously submitted to EPA on January 22, 2016, and supplemented on July 18, 2016 and November 29, 2016, for attaining the 1-hour sulfur dioxide (SO
                        <E T="52">2</E>
                        ) primary national ambient air quality standard (NAAQS) for the Rhinelander SO
                        <E T="52">2</E>
                         nonattainment area. This plan (herein referred to as Wisconsin's Rhinelander SO
                        <E T="52">2</E>
                         plan or plan) includes Wisconsin's attainment demonstration and other elements required under the Clean Air Act (CAA). In addition to an attainment demonstration, the plan addresses the requirement for meeting reasonable further progress (RFP) toward attainment of the NAAQS, reasonably available control measures and reasonably available control technology (RACM/RACT), and contingency measures. This action supplements a prior action which found that Wisconsin had satisfied emission inventory and new source review (NSR) requirements for this area, but had not met requirements for the elements approved here. In this action, EPA concludes that Wisconsin has appropriately demonstrated that the plan provisions provide for attainment of the 2010 1-hour primary SO
                        <E T="52">2</E>
                         NAAQS in the Rhinelander SO
                        <E T="52">2</E>
                         nonattainment area and that the plan meets the other applicable requirements under the CAA. EPA proposed to approve this action on July 22, 2021, and received no adverse comments.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This final rule is effective on December 31, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        EPA has established a docket for this action under Docket ID No. EPA-R05-OAR-2021-0256. All documents in the docket are listed on the 
                        <E T="03">www.regulations.gov</E>
                         website. Although listed in the index, some information is not publicly available, 
                        <E T="03">i.e.,</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 either through 
                        <E T="03">www.regulations.gov</E>
                         or at the Environmental Protection Agency, Region 5, Air and Radiation Division, 77 West Jackson Boulevard, Chicago, Illinois 60604. This facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays and facility closures due to COVID-19. We recommend that you telephone Abigail Teener, Environmental Engineer, at (312) 353-7314 before visiting the Region 5 office.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Abigail Teener, Environmental Engineer, Attainment Planning and Maintenance Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 353-7314, 
                        <E T="03">teener.abigail@epa.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.</P>
                <HD SOURCE="HD1">I. Background Information</HD>
                <P>
                    Following the promulgation in 2010 of a 1-hour primary SO
                    <E T="52">2</E>
                     NAAQS, on August 5, 2013, EPA designated the Rhinelander area within the State of Wisconsin as nonattainment for this NAAQS, in conjunction with designating multiple areas in other states as nonattainment (78 FR 47191). Wisconsin submitted a nonattainment plan for the Rhinelander area on January 22, 2016, and supplemented it on July 18, 2016, and November 29, 2016. On March 23, 2021, EPA partially approved and partially disapproved Wisconsin's Rhinelander SO
                    <E T="52">2</E>
                     plan as submitted and supplemented in 2016 (86 FR 15418). EPA approved the base-year emissions inventory and affirmed that the new source review requirements for the area had previously been met (79 FR 60064, October 6, 2014). EPA also approved the SO
                    <E T="52">2</E>
                     emission limit for Ahlstrom-Munksjö's Rhinelander facility (Ahlstrom-Munksjö) (formerly Expera Specialty Solutions LLC (Expera)) as SIP-strengthening. At that time, EPA disapproved the attainment demonstration for failing to comply with EPA's stack height regulations. Additionally, EPA disapproved the plan for failing to meet the requirements for RFP toward attainment of the NAAQS, RACM/RACT, emission limitations and control measures, as necessary to attain the NAAQS, and contingency measures. On March 29, 2021, Wisconsin 
                    <PRTPAGE P="58578"/>
                    submitted a permit containing a more stringent emission limit for Ahlstrom-Munksjö (2.38 pounds per million British Thermal Unit (lbs/MMBTU) on a 24-hour average basis) than the previous limit (3.0 lbs/MMBTU on a 24-hour average basis), supplemental information in order to remedy the plan's deficiencies specified in EPA's March 23, 2021 rulemaking, and a request that EPA approve its revised plan for the Rhinelander area.
                </P>
                <P>
                    EPA published a notice of proposed rulemaking addressing Wisconsin's revised plan for the Rhinelander SO
                    <E T="52">2</E>
                     nonattainment area on July 22, 2021 (86 FR 38643). EPA proposed to approve the sections of the tile I construction permit (Air Pollution Control Construction Permit Revision 15-DMM-128-R1) that contain the revised SO
                    <E T="52">2</E>
                     limit for Ahlstrom-Munksjö and the associated requirements. Additionally, EPA proposed to replace the previously approved consent and administrative orders (AM-94-38 and AM-15-01) governing the Ahlstrom-Munksjö emission limits with these elements of Permit 15-DMM-128-R1. EPA proposed to conclude that Wisconsin has demonstrated that these requirements provide for the Rhinelander area to attain the SO
                    <E T="52">2</E>
                     NAAQS. Finally, EPA proposed to conclude that Wisconsin has satisfied the other applicable requirements for nonattainment areas, including requirements for RACM/RACT, RFP, and contingency measures. The proposal supplemented a previous action in which EPA concluded that Wisconsin had met the requirement for a suitable emissions inventory.
                </P>
                <HD SOURCE="HD1">II. Public Comments</HD>
                <P>The public comment period for this proposed rule ended on August 23, 2021. During the comment period, EPA received one supportive comment on the proposal. The comment is included in the docket for this action.</P>
                <HD SOURCE="HD1">III. Final Action</HD>
                <P>
                    EPA is approving Wisconsin's SIP submission, which the State submitted to EPA on March 29, 2021, to supplement the prior SIP it had submitted on January 22, 2016, and supplemented on July 18, 2016, and November 29, 2016, for attaining the 2010 1-hour SO
                    <E T="52">2</E>
                     NAAQS for the Rhinelander area and for meeting other nonattainment area planning requirements. This SO
                    <E T="52">2</E>
                     attainment plan includes Wisconsin's attainment demonstration for the Rhinelander area. The plan also addresses requirements for RFP, RACT/RACM, and contingency measures. EPA has previously concluded that Wisconsin has addressed the requirements for emissions inventories for the Rhinelander area and nonattainment area NSR. EPA has determined that Wisconsin's Rhinelander SO
                    <E T="52">2</E>
                     plan meets applicable requirements of section 172 of the CAA.
                </P>
                <P>
                    Wisconsin's Rhinelander SO
                    <E T="52">2</E>
                     plan is based on the emissions limits specified in Air Pollution Control Construction Permit Revision 15-DMM-128-R1. Wisconsin seeks EPA to approve several elements of the permit, including the permit cover sheet, emissions limitations for Ahlstrom-Munksjö (Conditions A.3.a.(1)-(3)), the compliance demonstration (Conditions A.3.b.(1)-(3)), reference test methods, recordkeeping and monitoring requirements (Conditions A.3.c.(1)-(5) and A.3.c.(7)-(9)), and the effective date (Condition YYY.1.a.(1)). Wisconsin did not seek approval of limits and test methods associated with oil sulfur content. Wisconsin stated that limits on the portion of emissions from oil are unnecessary to comply with the 24-hour SO
                    <E T="52">2</E>
                     emission limit and the boiler heat input limit, and attainment is ensured by limits on total emissions from boiler B26. EPA concurs with Wisconsin's rationale, and therefore EPA is approving these elements of the permit.
                </P>
                <P>
                    Additionally, EPA is replacing the previously approved consent and administrative orders (AM-94-38 and AM-15-01) governing the Ahlstrom-Munksjö emission limits 
                    <SU>1</SU>
                    <FTREF/>
                     with the elements of Wisconsin's Air Pollution Control Construction Permit Revision 15-DMM-128-R1 specified above. This replacement will not be effective until December 31, 2021, which is the revised permit compliance date for Ahlstrom-Munksjö. Section 110(l) of the CAA states that EPA “shall not approve a revision of a plan if the revision would interfere with any applicable requirement. . . .” Since Permit 15-DMM-128-R1 contains a more stringent SO
                    <E T="52">2</E>
                     limit for Ahlstrom-Munksjö (2.38 lbs/MMBTU on a 24-hour average basis) than the previous orders (3.0 lbs/MMBTU on a 24-hour average basis), and since Wisconsin has demonstrated that the limit in Permit 15-DMM-128-R1 provides for attainment without need for the limits in the prior orders, EPA concludes that Section 110(l) does not prohibit EPA from replacing the prior orders with the newer permit, and EPA is acting in accordance with this Wisconsin request.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Orders AM-94-38 and AM-15-01 were issued to the facility's prior owner, Expera, but the orders continued to limit the facility's emissions after it was acquired by Ahlstrom-Munksjö.
                    </P>
                </FTNT>
                <P>This approval terminates the sanctions clock started under CAA section 179 resulting from EPA's partial disapproval of the prior SIP, as well as EPA's duty to promulgate a FIP for the area under CAA section 110(c) that resulted from the previous partial disapproval.</P>
                <HD SOURCE="HD1">IV. Incorporation by Reference</HD>
                <P>
                    In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Wisconsin Regulations described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available through 
                    <E T="03">www.regulations.gov,</E>
                     and at the EPA Region 5 Office (please contact the person identified in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section of this preamble for more information).
                </P>
                <P>Also in this document, as described in the amendments to 40 CFR part 52 set forth below, EPA is removing provisions of the EPA-Approved Wisconsin Regulations and Statutes from the Wisconsin State Implementation Plan, which is incorporated by reference in accordance with the requirements of 1 CFR part 51.</P>
                <HD SOURCE="HD1">V. Statutory and Executive Order Reviews</HD>
                <P>Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this 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>
                    );
                    <PRTPAGE P="58579"/>
                </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);</P>
                <P>• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and</P>
                <P>• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).</P>
                <P>In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where 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 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>
                    The Congressional Review Act, 5 U.S.C. 801 
                    <E T="03">et seq.,</E>
                     as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the 
                    <E T="04">Federal Register</E>
                    . A major rule cannot take effect until 60 days after it is published in the 
                    <E T="04">Federal Register</E>
                    . 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 CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 21, 2021. 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. (
                    <E T="03">See</E>
                     section 307(b)(2).)
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 40 CFR Part 52</HD>
                    <P>Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements, Sulfur oxides.</P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated: October 8, 2021.</DATED>
                    <NAME>Cheryl Newton,</NAME>
                    <TITLE>Acting Regional Administrator, Region 5.</TITLE>
                </SIG>
                <P>For the reasons stated in the preamble, EPA amends 40 CFR part 52 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>
                </REGTEXT>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>2. Section 52.2570 is amended by removing and reserving paragraphs (c)(79)(i)(A) and (c)(142) and adding paragraph (c)(144) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 52.2570 </SECTNO>
                        <SUBJECT>Identification of plan.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>
                            (144) On March 29, 2021, the Wisconsin Department of Natural Resources submitted a request to revise the Wisconsin State Implementation Plan for attaining the 2010 primary, health-based 1-hour SO
                            <E T="52">2</E>
                             national ambient air quality standard for the Rhinelander SO
                            <E T="52">2</E>
                             nonattainment area. This submittal supplements the 2016 plan for the Rhinelander area and includes an attainment demonstration and a title I construction permit for Ahlstrom-Munksjö's Rhinelander facility. The revised plan also addresses the requirement for meeting reasonable further progress toward attainment of the national ambient air quality standard, reasonably available control measures and reasonably available control technology, and contingency measures.
                        </P>
                        <P>
                            (i) 
                            <E T="03">Incorporation by reference.</E>
                             Elements of Air Pollution Control Construction Permit Revision 15-DMM-128-R1, issued by the Wisconsin Department of Natural Resources on March 25, 2021 to Ahlstrom-Munksjö Rhinelander LLC, including the permit cover sheet, SO
                            <E T="52">2</E>
                             emissions limitations for Ahlstrom-Munksjö (Conditions A.3.a.(1)-(3)), a compliance demonstration (Conditions A.3.b.(1)-(3)), reference test methods, recordkeeping and monitoring requirements (Conditions A.3.c.(1)-(5) and A.3.c.(7)-(9)), and the effective date (Condition YYY.1.a.(1)).
                        </P>
                        <P>(ii) [Reserved]</P>
                    </SECTION>
                </REGTEXT>
                <SECTION>
                    <SECTNO>§ 52.2572 </SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>3. Section 52.2572 is amended by removing and reserving paragraph (c).</AMDPAR>
                </REGTEXT>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>4. Section 52.2575 is amended by adding paragraph (a)(2) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 52.2575 </SECTNO>
                        <SUBJECT>Control strategy: Sulfur dioxide.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>
                            (2) Attainment demonstration—submitted on January 22, 2016, supplemented on July 18, 2016, and November 29, 2016, and revised on March 29, 2021 for the Rhinelander SO
                            <E T="52">2</E>
                             nonattainment area.
                        </P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-22601 Filed 10-21-21; 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-2021-0242; FRL-8725-02-R9]</DEPDOC>
                <SUBJECT>Air Plan Approval; Nevada, Las Vegas Valley; Second 10-Year Carbon Monoxide Limited Maintenance Plan</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 approve a Nevada State Implementation Plan (SIP) revision submitted by the Nevada Department of Environmental Protection (NDEP). On September 27, 2010, the EPA redesignated the Las Vegas Valley area from nonattainment to attainment for the carbon monoxide (CO) national ambient air quality standard (NAAQS) and approved the State's CO maintenance plan ensuring the area would maintain the NAAQS for ten years through 2020. On June 18, 2019, NDEP submitted to the EPA a second 10-year limited maintenance plan for the Las Vegas Valley area that addresses maintenance of the CO NAAQS for a second 10-year period ending December 31, 2030.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective on November 22, 2021.</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-2021-0242. All documents in the docket are listed on the 
                        <E T="03">https://www.regulations.gov</E>
                          
                        <PRTPAGE P="58580"/>
                        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 disabilities 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>
                        John J. Kelly, Air Planning Office (AIR-2), EPA Region IX, (415) 947-4151, 
                        <E T="03">kelly.johnj@epa.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <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. Summary of Proposed Action</FP>
                    <FP SOURCE="FP-2">II. Public Comments</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. Summary of Proposed Action</HD>
                <P>
                    On August 2, 2021, under Clean Air Act (CAA or “Act”) section 110(k)(3), the EPA proposed to approve the “Second 10-Year Carbon Monoxide Limited Maintenance Plan: Las Valley Maintenance Area, Clark County, Nevada (May 2019)” (“2019 LMP” or “Plan”) submitted by NDEP on June 18, 2019, as a revision to the Nevada SIP.
                    <SU>1</SU>
                    <FTREF/>
                     In so doing, we found that the 2019 LMP adequately demonstrates that the area will maintain the CO NAAQS through the end of the second ten-year period of the maintenance period. We are taking final action to approve the 2019 LMP because it meets all applicable requirements under CAA sections 110 and 175A.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         See 86 FR 41416. NDEP submitted the 2019 LMP electronically to the EPA on June 18, 2019. NDEP's transmittal letter for the 2019 LMP is dated June 13, 2019.
                    </P>
                </FTNT>
                <P>Specific requirements of LMPs and the rationale for the EPA's proposed actions are discussed in the notice of proposed rulemaking and will not be restated here. Please see our August 2, 2021 proposed rule for background on this action and the rationale for approval of the 2019 LMP.</P>
                <HD SOURCE="HD1">II. Public Comments</HD>
                <P>Our August 2, 2021 proposed rule provided a 30-day public comment period that closed on September 1, 2021. We received no comments on our proposed action.</P>
                <HD SOURCE="HD1">III. Final Action</HD>
                <P>The EPA is taking final action to approve the 2019 LMP as a revision to the Nevada SIP. The EPA is approving the 2019 LMP for the reasons set forth in our August 2, 2021 proposed rule and because the Plan is consistent with the requirements of the CAA.</P>
                <HD SOURCE="HD1">IV. Statutory and Executive Order Reviews</HD>
                <P>
                    Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(K); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the 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. 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 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 for review.</P>
                <HD SOURCE="HD2">B. Paperwork Reduction Act (PRA)</HD>
                <P>This action does not impose an information collection burden under the PRA because this action 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: Coordination With Indian Tribal Governments</HD>
                <P>This action does not have tribal implications, as specified in Executive Order 13175, because this action does 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 costs on tribal governments or preempt tribal law. The Las Vegas Valley CO maintenance area includes areas of Indian country of the Las Vegas Tribe of Paiute Indians. In those areas of Indian country, the 2019 LMP does not apply, and therefore, this action does not have tribal implications and 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>
                <HD SOURCE="HD2">G. Executive Order 13045: Protection of Children From Environmental Health Risks 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 not impose additional requirements beyond those imposed by state law.</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 and Advancement Act (NTTAA)</HD>
                <P>
                    Section 12(d) of the NTTAA directs the EPA to use voluntary consensus standards in its regulatory activities 
                    <PRTPAGE P="58581"/>
                    unless to do so would be inconsistent with applicable law or otherwise impractical. The EPA believes that this action is not subject to the requirements of section 12(d) of the NTTAA because application of those requirements would be inconsistent with the CAA.
                </P>
                <HD SOURCE="HD2">J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations</HD>
                <P>The EPA lacks the discretionary authority to address environmental justice in this action.</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 December 21, 2021. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule 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, Incorporation by reference, Intergovernmental relations, Carbon monoxide, 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: October 13, 2021.</DATED>
                    <NAME>Deborah Jordan,</NAME>
                    <TITLE>Acting Regional Administrator, Region IX.</TITLE>
                </SIG>
                <P>Chapter I, title 40 of the Code of Federal Regulations 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>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart DD—Nevada</HD>
                </SUBPART>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>2. In § 52.1470(e), the table is amended by adding an entry for “Second 10-year Carbon Monoxide Limited Maintenance Plan, Las Vegas Valley Maintenance Area, Clark County, Nevada (May 2019)” after the entry for “Resolution of the Clark County Board of Commissioners Adopting the Clark County Carbon Monoxide Redesignation Request and Maintenance Plan, adopted by the Clark County Board of Commissioners on September 2, 2008” to read as follows.</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 52.1470 </SECTNO>
                        <SUBJECT>Identification of plan.</SUBJECT>
                        <STARS/>
                        <P>(e) * * *</P>
                        <GPOTABLE COLS="05" OPTS="L1,i1" CDEF="s50,r50,xs66,r50,r50">
                            <TTITLE>EPA-Approved Nevada Nonregulatory and Quasi-Regulatory Measures</TTITLE>
                            <BOXHD>
                                <CHED H="1">Name of SIP provision</CHED>
                                <CHED H="1">Applicable geographic or nonattainment area or title/subject</CHED>
                                <CHED H="1">State submittal date</CHED>
                                <CHED H="1">EPA approval date</CHED>
                                <CHED H="1">Explanation</CHED>
                            </BOXHD>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">Air Quality Implementation Plans for the State of Nevada</E>
                                     
                                    <SU>1</SU>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Second 10-year Carbon Monoxide Limited Maintenance Plan, Las Vegas Valley Maintenance Area, Clark County, Nevada (May 2019)</ENT>
                                <ENT>Las Vegas Valley, Clark County</ENT>
                                <ENT>June 18, 2019</ENT>
                                <ENT>
                                    October 22, 2021, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Fulfills requirement for second ten-year maintenance plan.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <TNOTE>    *         *         *         *         *         *         *</TNOTE>
                            <TNOTE>
                                <SU>1</SU>
                                 The organization of this table generally follows from the organization of the State of Nevada's original 1972 SIP, which was divided into 12 sections. Nonattainment and maintenance plans, among other types of plans, are listed under Section 5 (Control Strategy). Lead SIPs and Small Business Stationary Source Technical and Environmental Compliance Assistance SIPs are listed after Section 12 followed by nonregulatory or quasi-regulatory statutory provisions approved into the SIP. Regulatory statutory provisions are listed in 40 CFR 52.1470(c).
                            </TNOTE>
                        </GPOTABLE>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-22714 Filed 10-21-21; 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-2020-0425; FRL-8723-02-R9]</DEPDOC>
                <SUBJECT>Approval of Air Quality Implementation Plans; California; Sacramento Metro Area; 2008 8-Hour Ozone Nonattainment Area Requirements</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 approve portions of two state implementation plan (SIP) revisions submitted by the State of California to meet Clean Air Act (CAA or “Act”) requirements for the 2008 8-hour ozone national ambient air quality standards (NAAQS or “standards”) in the Sacramento Metro ozone nonattainment area (“Sacramento Metro Area”). These SIP revisions address the CAA nonattainment area requirements for the 2008 ozone NAAQS, such as the requirements for an emissions inventory, an attainment demonstration, 
                        <PRTPAGE P="58582"/>
                        reasonable further progress, reasonably available control measures, and contingency measures, and it establishes motor vehicle emissions budgets. The EPA is taking final action to approve these revisions as meeting all the applicable ozone nonattainment area requirements, except for the State's contingency measures revision. The EPA is deferring action on this revision related to contingency measures.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule will be effective on November 22, 2021.</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-2020-0425. 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 disabilities 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>
                        Jerry Wamsley, Air Planning Office (AIR-2), EPA Region IX, 75 Hawthorne Street, San Francisco, CA 94105, (415) 947-4111 or 
                        <E T="03">Wamsley.Jerry@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Table of Contents</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Summary of the Proposed Action</FP>
                    <FP SOURCE="FP-2">II. Public Comments and EPA Responses</FP>
                    <FP SOURCE="FP1-2">
                        A. Review of Ozone Chemistry and NO
                        <E T="52">X</E>
                         Substitution Effects
                    </FP>
                    <FP SOURCE="FP1-2">B. Response to Comments</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. Summary of the Proposed Action</HD>
                <P>
                    On October 29, 2020, the EPA proposed to approve, under CAA section 110(k)(3), and to conditionally approve, under CAA section 110(k)(4), portions of submittals from the State of California as revisions to the California SIP for the Sacramento Metro ozone nonattainment area.
                    <SU>1</SU>
                    <FTREF/>
                     The principal submittals are as follows: “Sacramento Regional 2008 NAAQS 8-Hour Ozone Attainment Plan and Reasonable Further Progress Plan,” (“2017 Sacramento Regional Ozone Plan”); and the Sacramento Metro portion of the California Air Resource Board's (CARB) “2018 Updates to the California State Implementation Plan” (“2018 SIP Update”).
                    <SU>2</SU>
                    <FTREF/>
                     In this notice, we refer to these submittals collectively as the “Sacramento Metro Area Ozone SIP” or the “Plan,” and we refer to our October 29, 2020 proposed action as the “proposed rule.”
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         85 FR 68509 (October 29, 2020).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         The State submitted the 2017 Sacramento Regional Ozone Plan and the 2018 SIP Update on December 18, 2017, and December 5, 2018, respectively. Our proposed rule provides our detailed review of CAA procedural requirements related to these submissions.
                    </P>
                </FTNT>
                <P>
                    The Sacramento Metro Area consists of Sacramento and Yolo counties and portions of El Dorado, Placer, Solano, and Sutter counties.
                    <SU>3</SU>
                    <FTREF/>
                     Several local air agencies have their jurisdictions within this area. Sacramento County is under the jurisdiction of the Sacramento Metropolitan Air Quality Management District (SMAQMD). Yolo County and the eastern portion of Solano County are under the jurisdiction of the Yolo-Solano AQMD (YSAQMD). The southern portion of Sutter County is under the jurisdiction of the Feather River AQMD (FRAQMD). The western portion of Placer County is under the jurisdiction of the Placer County Air Pollution Control District (PCAPCD). Last, the western portion of El Dorado County is under the jurisdiction of the El Dorado County AQMD (EDCAQMD). In this action, we refer to these five districts collectively as the “Districts.” Under California law, each air district is responsible for adopting and implementing stationary source rules, while CARB adopts and implements consumer products and mobile source rules. The Districts' and State's rules are submitted to the EPA by CARB.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         For a precise description of the geographic boundaries of the Sacramento Metro Area for the 2008 ozone standards, refer to 40 CFR 81.305. Specifically included portions are the eastern portion of Solano County, the western portions of Placer and El Dorado counties outside of the Lake Tahoe Basin, and the southern portion of Sutter County.
                    </P>
                </FTNT>
                <P>
                    In our proposed rule, we provided background information on the ozone standards,
                    <SU>4</SU>
                    <FTREF/>
                     area designations, related SIP revision requirements under the CAA, and the EPA's implementing regulations for the 2008 ozone standards, referred to as the 2008 Ozone SIP Requirements Rule (“2008 Ozone SRR”). To summarize, the Sacramento Metro Area is classified as Severe nonattainment for the 2008 ozone standards; consequently, the Sacramento Metro Area Ozone SIP was developed to address the CAA requirements for this Severe nonattainment area in meeting the 2008 ozone NAAQS.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Ground-level ozone pollution is formed from the reaction of volatile organic compounds (VOC) and oxides of nitrogen (NO
                        <E T="52">X</E>
                        ) in the presence of sunlight. The 1-hour ozone NAAQS is 0.12 parts per million (ppm) (one-hour average), the 1997 ozone NAAQS is 0.08 ppm (eight-hour average), and the 2008 ozone NAAQS is 0.075 ppm (eight-hour average). CARB refers to reactive organic gases (ROG) in some of its ozone-related submittals. The CAA and the EPA's regulations refer to VOC, rather than ROG, but both terms cover essentially the same set of gases. In this final rule, we use the term VOC to refer to this set of gases.
                    </P>
                </FTNT>
                <P>
                    In our proposed rule, we also discussed a decision issued by the D.C. Circuit Court of Appeals in 
                    <E T="03">South Coast Air Quality Management Dist.</E>
                     v. 
                    <E T="03">EPA</E>
                     (“
                    <E T="03">South Coast II</E>
                    ”) 
                    <SU>5</SU>
                    <FTREF/>
                     that vacated certain portions of the EPA's 2008 Ozone SRR. The only aspect of the 
                    <E T="03">South Coast II</E>
                     decision that affects this action is the vacatur of the provision in the 2008 Ozone SRR that allowed states to use an alternative baseline year for demonstrating reasonable further progress (RFP). To address this decision, CARB, in the 2018 SIP Update, submitted an updated RFP demonstration that relied on a 2011 baseline year, as required, along with updated motor vehicle emissions budgets (MVEBs or “budgets”) associated with the new RFP milestone years.
                    <SU>6</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">South Coast Air Quality Management Dist.</E>
                         v. 
                        <E T="03">EPA,</E>
                         882 F.3d 1138 (D.C. Cir. 2018). The term “
                        <E T="03">South Coast II</E>
                        ” is used in reference to the 2018 court decision to distinguish it from a decision published in 2006 also referred to as “
                        <E T="03">South Coast.</E>
                        ” The earlier decision involved a challenge to the EPA's Phase 1 implementation rule for the 1997 ozone NAAQS. 
                        <E T="03">South Coast Air Quality Management Dist.</E>
                         v. 
                        <E T="03">EPA,</E>
                         472 F.3d 882 (D.C. Cir. 2006).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         In a letter dated December 18, 2019, from Richard W. Corey, Executive Officer, CARB, to Michael Stoker, Regional Administrator, EPA Region 9, CARB requested withdrawal of the RFP demonstration included in the 2017 Sacramento Regional Ozone Plan submitted previously. The RFP demonstration in the 2018 SIP Update replaced the demonstration in the 2017 Plan.
                    </P>
                </FTNT>
                <P>Within our proposed rule, we reviewed the various SIP elements contained in the Sacramento Metro Area Ozone SIP, evaluated them for compliance with CAA statutory and regulatory requirements, and concluded that they met all applicable requirements, with the exception of the contingency measures element, for which the EPA proposed conditional approval. Below, we provide a summary review of our proposed rule, by SIP element.</P>
                <P>
                    • We found that CARB and the Districts met all applicable procedural requirements for public notice and hearing prior to the adoption and submittal of the components of the Sacramento Metro Area Ozone SIP, 
                    <E T="03">i.e.,</E>
                      
                    <PRTPAGE P="58583"/>
                    the 2017 Sacramento Regional Ozone Plan and the Sacramento Metro portion of CARB's 2018 SIP Update.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         85 FR 68509, 68511-68512.
                    </P>
                </FTNT>
                <P>
                    • We proposed to approve the base year emissions inventory element in the 2017 Sacramento Regional Ozone Plan as meeting the requirements of CAA sections 172(c)(3) and 182(a)(1) and 40 CFR 51.1115 for the 2008 ozone NAAQS. Based on our review, we proposed to find that the future year baseline projections in the 2017 Sacramento Regional Ozone Plan are properly supported by SIP-approved stationary and mobile source measures.
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Id. at 68513-68515.
                    </P>
                </FTNT>
                <P>
                    • We proposed to approve the reasonably available control measures (RACM) demonstration element in the 2017 Sacramento Regional Ozone Plan as meeting the requirements of CAA section 172(c)(1) and 40 CFR 51.1112(c) for the 2008 ozone NAAQS. Based on our review of the State and Districts' RACM analyses and the Districts' and CARB's adopted rules, we proposed to find that there are, at this time, no additional RACM that would further advance attainment of the 2008 ozone NAAQS in the Sacramento Metro Area.
                    <SU>9</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         Id. at 68516-68518.
                    </P>
                </FTNT>
                <P>
                    • We proposed to approve the attainment demonstration element for the 2008 ozone NAAQS in the 2017 Sacramento Regional Ozone Plan as meeting the requirements of CAA section 182(c)(2)(A) and 40 CFR 51.1108. In our review provided in the proposed rule, we observed that the Plan followed the modeling procedures recommended in the EPA's Modeling Guidance and showed excellent performance in simulating observed ozone concentrations in the 2012 base year. Given the extensive discussion of modeling procedures, tests, and performance analyses called for in the modeling protocol, the good model performance, and the model response to emissions changes consistent with observations, we proposed to find that the modeling is adequate for purposes of supporting the attainment demonstration.
                    <SU>10</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         Id. at 68518-68523.
                    </P>
                </FTNT>
                <P>
                    • We proposed to approve the rate of progress (ROP) demonstration element in the 2017 Sacramento Regional Ozone Plan as meeting the requirements of CAA 182(b)(1) and 40 CFR 51.1110(a)(2) for the 2008 ozone NAAQS.
                    <SU>11</SU>
                    <FTREF/>
                     As noted in the proposed rule, in 2015, the EPA approved a 15 percent ROP plan for the Sacramento Metro Area for the 1-hour ozone NAAQS and 1997 8-hour ozone NAAQS.
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         Id. at 68523-68525
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         80 FR 4795 (January 29, 2015).
                    </P>
                </FTNT>
                <P>
                    • We proposed to approve the RFP demonstration element in Section V—SIP Elements for the Sacramento Metropolitan Area of the 2018 SIP Update (as clarified) as meeting the requirements of CAA sections 172(c)(2), 182(b)(1), and 182(c)(2)(B), and 40 CFR 51.1110(a)(2)(ii) for the 2008 ozone NAAQS. We proposed to find that CARB and the Districts used the most recent planning and activity assumptions, emissions models, and methodologies in developing the RFP baseline and milestone year emissions inventories. Also, we proposed to find that the Districts and CARB used an appropriate calculation method to demonstrate RFP. Lastly, we proposed to find that the Districts' use of oxides of nitrogen (NO
                    <E T="52">X</E>
                    ) NAAQS substitution is warranted and appropriately implemented based on the NO
                    <E T="52">X</E>
                    -limited conditions in the Sacramento Metro Area, and the area's greater responsiveness to NO
                    <E T="52">X</E>
                     emissions reductions relative to VOC emissions reductions.
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         85 FR 68509, 68523-68525.
                    </P>
                </FTNT>
                <P>
                    • We proposed to approve the vehicle miles traveled (VMT) emissions offset demonstration element in the 2017 Sacramento Regional Ozone Plan as meeting the requirements of CAA section 182(d)(1)(A) and 40 CFR 51.1102 for the 2008 ozone NAAQS. Based on our review of revised Sacramento Metro Area VMT emissions offset demonstration in the 2017 Sacramento Regional Ozone Plan, we proposed to find that CARB's analysis is consistent with the August 2012 Guidance and with the emissions and vehicle activity estimates found elsewhere in the 2017 Sacramento Regional Ozone Plan. Also, we proposed to find that CARB and the Sacramento Area Council of Governments (SACOG) have adopted sufficient transportation control strategies (TCSs) and transportation control measures (TCMs) to offset the growth in emissions from growth in VMT and vehicle trips in the Sacramento Metro Area for the purposes of the 2008 ozone NAAQS.
                    <SU>14</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         Id. at 68525-68527.
                    </P>
                </FTNT>
                <P>
                    • We proposed to approve the MVEBs in Section V—SIP Elements for the Sacramento Metropolitan Area of the 2018 SIP Update for the RFP milestone year of 2023, and the attainment year of 2024 and find that these budgets are consistent with the RFP and attainment demonstrations for the 2008 ozone NAAQS proposed for approval and the budgets meet the other criteria in 40 CFR 93.118(e).
                    <SU>15</SU>
                    <FTREF/>
                     We reviewed the budgets in the Sacramento Metro Area Ozone SIP and proposed to find that they are consistent with the attainment and RFP demonstrations for which we proposed approval, are based on control measures that have already been adopted and implemented, and meet all other applicable statutory and regulatory requirements including the adequacy criteria in 40 CFR 93.1118(e)(4) and (5).
                    <SU>16</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         Table 9 in our proposed rule provides the VOC and NO
                        <E T="52">X</E>
                         emissions budgets that we proposed for approval.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         85 FR 68509, 68529-68531.
                    </P>
                </FTNT>
                <P>We also proposed to make the following findings related to other CAA requirements:</P>
                <P>
                    • The emissions statement element of the 2017 Sacramento Regional Ozone Plan satisfies the requirements under CAA section 182(a)(3)(B) based on our prior approvals of the Districts' emission statement rules; 
                    <SU>17</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         Id. at 68515-68516.
                    </P>
                </FTNT>
                <P>
                    • The enhanced vehicle inspection and maintenance program in the Sacramento Metro Area meets the requirements of CAA section 182(c)(3) and 40 CFR 51.1102 for the 2008 ozone NAAQS; 
                    <SU>18</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         Id. at 68531.
                    </P>
                </FTNT>
                <P>
                    • The California SIP revision to opt out of the Federal Clean Fuels Fleet Program meets the requirements of CAA sections 182(c)(4)(A) and 246 and 40 CFR 51.1102 for the 2008 ozone NAAQS with respect to the Sacramento Metro Area; 
                    <SU>19</SU>
                    <FTREF/>
                     and,
                </P>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         Id.
                    </P>
                </FTNT>
                <P>
                    • The enhanced air quality monitoring in the Sacramento Metro Area meets the requirements of CAA section 182(c)(1) and 40 CFR 51.1102 for the 2008 ozone NAAQS.
                    <SU>20</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         Id. at 68531-68532.
                    </P>
                </FTNT>
                <P>
                    Finally, under CAA section 110(k)(4), we proposed to approve conditionally the contingency measures element of the Sacramento Metro Area Ozone SIP as meeting the requirements of CAA sections 172(c)(9) and 182(c)(9) for RFP and attainment contingency measures. Our proposed approval was based on commitments by the Districts and CARB to supplement the element through submission, as a SIP revision within one year of our final conditional approval action, of new or revised rules with more stringent requirements sufficient to produce near to one year's RFP if an RFP milestone is not met, as well as continuing emission reductions from State mobile source control measures.
                    <SU>21</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         Id. at 68527-68529.
                    </P>
                </FTNT>
                <P>
                    Please see our proposed rule and the docket for more information concerning the background of this final action and 
                    <PRTPAGE P="58584"/>
                    for a detailed discussion of the rationale for approval or conditional approval of the above-listed elements of the Sacramento Metro Area Ozone SIP.
                </P>
                <HD SOURCE="HD1">II. Public Comments and EPA Responses</HD>
                <P>
                    The public comment period on the proposed rule opened on October 29, 2020, the date of its publication in the 
                    <E T="04">Federal Register</E>
                    , and closed on November 30, 2020. During this period, the EPA received one comment letter submitted by Air Law for All on behalf of the Center for Biological Diversity and the Center for Environmental Health (collectively referred to as “CBD” herein). Before we provide a detailed summary of and response to each of these comments in Section II.B, we provide a brief review of ozone chemistry and terminology as it relates to our responses to comments concerning the Plan's use of NO
                    <E T="52">X</E>
                     substitution and the NO
                    <E T="52">X</E>
                    -limited conditions in the Sacramento Metro Area.
                </P>
                <HD SOURCE="HD2">
                    A. Review of Ozone Chemistry and NO
                    <E T="54">X</E>
                     Substitution Effects
                </HD>
                <P>
                    As explained in the proposed rule, ground-level ozone pollution is formed from the reaction of volatile organic compounds (VOCs) and NO
                    <E T="52">X</E>
                     in the presence of sunlight. When VOC is abundant compared to NO
                    <E T="52">X</E>
                    , 
                    <E T="03">i.e.,</E>
                     when there is a high ratio of VOCs relative to NO
                    <E T="52">X</E>
                     (“VOC:NO
                    <E T="52">X</E>
                     ratio”), NO
                    <E T="52">X</E>
                     is a limiting ingredient for ozone formation, and reducing NO
                    <E T="52">X</E>
                     emissions causes ozone to decrease. An area with these conditions may be described as “NO
                    <E T="52">X</E>
                    -limited,” which is the terminology used in this notice. Elsewhere, “NO
                    <E T="52">X</E>
                    -limited” is sometimes used in a stronger, relative sense to mean that NO
                    <E T="52">X</E>
                     emissions reductions are 
                    <E T="03">more</E>
                     effective than VOC reductions at reducing ozone, and an area may be described as “NO
                    <E T="52">X</E>
                    -limited” or “VOC-limited” as a shorthand for whether NO
                    <E T="52">X</E>
                     or VOC emissions reductions are more effective at reducing the area's ozone design value.
                    <SU>22</SU>
                    <FTREF/>
                     In contrast, in a “NO
                    <E T="52">X</E>
                    -saturated” area where NO
                    <E T="52">X</E>
                     is abundant compared to VOC, 
                    <E T="03">i.e.,</E>
                     when there is a low VOC:NO
                    <E T="52">X</E>
                     ratio, ozone concentrations typically 
                    <E T="03">increase</E>
                     with NO
                    <E T="52">X</E>
                     emission reductions, that is, there is a “NO
                    <E T="52">X</E>
                     disbenefit.” 
                    <SU>23</SU>
                    <FTREF/>
                     Between the NO
                    <E T="52">X</E>
                    -limited and NO
                    <E T="52">X</E>
                    -saturated ozone chemistry regimes, there is an intermediate “transitional” regime where ozone responds weakly to NO
                    <E T="52">X</E>
                     emissions reductions. Which one of these three chemical regimes exists for an area can depend on the season, time of day, and the area's location relative to a source of NO
                    <E T="52">X</E>
                     emissions. As one moves farther downwind from an urban center, ozone formation tends to become more NO
                    <E T="52">X</E>
                    -limited, as the VOC:NO
                    <E T="52">X</E>
                     ratio increases. While there are continued VOC emissions in rural areas, there are fewer new NO
                    <E T="52">X</E>
                     emissions from combustion sources, and some NO
                    <E T="52">X</E>
                     deposits out of the atmosphere (in the form of HNO
                    <E T="52">3</E>
                    ); as a result, peak ozone hours and downwind locations are more NO
                    <E T="52">X</E>
                    -limited than non-peak hours and upwind or central locations.
                    <SU>24</SU>
                    <FTREF/>
                     When an area reduces NO
                    <E T="52">X</E>
                     emissions more than VOC emissions, the VOC:NO
                    <E T="52">X</E>
                     ratio increases and the area can transition from NO
                    <E T="52">X</E>
                    -saturated to NO
                    <E T="52">X</E>
                    -limited conditions. In general, areas in the United States have become more NO
                    <E T="52">X</E>
                    -limited over time, though NO
                    <E T="52">X</E>
                    -saturated areas and seasons remain.
                    <SU>25</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         For example, the Plan generally uses the term “NO
                        <E T="52">X</E>
                        -limited” to mean that NO
                        <E T="52">X</E>
                         emission reductions in the Sacramento Metro Area are more effective than VOC at decreasing ozone; 
                        <E T="03">e.g.,</E>
                         2017 Sacramento Regional Ozone Plan, Appendix B-4, page B-146, Figure 13 (labeling as “NO
                        <E T="52">X</E>
                        -limited” the region of a typical ozone isopleth plot where NO
                        <E T="52">X</E>
                         reductions are more effective than VOC reductions).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         A NO
                        <E T="52">X</E>
                         disbenefit can occur under NO
                        <E T="52">X</E>
                        -saturated conditions because enough NO
                        <E T="52">X</E>
                         is present to interfere with ozone formation via VOC. VOC radicals require the hydroxyl radical (OH) to form, but OH is made unavailable when NO
                        <E T="52">X</E>
                         combines with it to form nitric acid (HNO
                        <E T="52">3</E>
                        ), which then deposits out of the atmosphere. A reduction in NO
                        <E T="52">X</E>
                         emissions reduces this OH sink reaction, increasing the OH available to form VOC radicals and ozone.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         Barbara J. Finlayson-Pitts and James N. Pitts Jr., “Tropospheric Air Pollution: Ozone, Airborne Toxics, Polycyclic Aromatic Hydrocarbons, and Particles,” 
                        <E T="03">Science,</E>
                         Vol. 276, May 16, 1997; EPA, U. S., Health Risk and Exposure Assessment for Ozone Final Report. Office of Air Quality Planning and Standards: RTP, NC, 2014; EPA-452/R-14-004a, 
                        <E T="03">https://www.epa.gov/naaqs/ozone-o3-standards-risk-and-exposure-assessments-review-completed-2015.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         Wolff, G.T., Kahlbaum, D.F., &amp; Heuss, J.M., 2013. “The vanishing ozone weekday/weekend effect,” 
                        <E T="03">Journal of the Air &amp; Waste Management Association</E>
                        ), 63(3), 292-299, 
                        <E T="03">https://doi.org/10.1080/10962247.2012.749312</E>
                         Jin et al., 2017, “Evaluating a space-based indicator of surface ozone NO
                        <E T="52">X</E>
                         VOC sensitivity over midlatitude source regions and application to decadal trends,” 
                        <E T="03">Journal of Geophysical Research: Atmospheres,</E>
                         122,10,439 10,461. 
                        <E T="03">https://doi.org/10.1002/2017JD026720;</E>
                         Sicard et al, 2020, “Ozone weekend effect in cities: Deep insights for urban air pollution control,” 
                        <E T="03">Environmental Research,</E>
                         191, 110193. 
                        <E T="03">https://doi.org/10.1016/j.envres.2020.110193.</E>
                    </P>
                </FTNT>
                <P>
                    NO
                    <E T="52">X</E>
                     is emitted primarily in the form of nitric oxide (NO), which becomes nitrogen dioxide (NO
                    <E T="52">2</E>
                    ) as it converts or “titrates” ozone (O
                    <E T="52">3</E>
                    ) to regular oxygen (O
                    <E T="52">2</E>
                    ). Therefore, the initial effect of a NO
                    <E T="52">X</E>
                     emissions increase can be to decrease ozone immediately downwind of a NO
                    <E T="52">X</E>
                     source, such as downtown metropolitan areas or a large fossil fuel burning power plant.
                    <SU>26</SU>
                    <FTREF/>
                     Farther downwind from the NO
                    <E T="52">X</E>
                     source, however, the NO
                    <E T="52">X</E>
                     can increase ozone, via reactions with VOC. Conversely, the initial effect of a NO
                    <E T="52">X</E>
                     emissions reduction, which is mainly a NO reduction, can be to increase ozone immediately downwind from the NO
                    <E T="52">X</E>
                     source because there is less remaining NO to titrate ozone to oxygen. Because of this phenomenon, it may be impossible for an area to be “NO
                    <E T="52">X</E>
                    -limited” at all locations, at least with respect to a given change in NO
                    <E T="52">X</E>
                     emissions occurring just upwind of a given location or monitor. Titration can occur under any ozone chemistry regime whether NO
                    <E T="52">X</E>
                    -saturation, NO
                    <E T="52">X</E>
                    -transitional, or NO
                    <E T="52">X</E>
                    -limited.
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         EPA, Health Risk and Exposure Assessment for Ozone Final Report, 2-5.
                    </P>
                </FTNT>
                <P>
                    To summarize, under certain conditions, NO
                    <E T="52">X</E>
                     emissions can reduce existing ozone concentrations in nearby downwind areas through titration and can interfere with the formation of ozone in NO
                    <E T="52">X</E>
                    -saturated areas. Reducing NO
                    <E T="52">X</E>
                     emissions can lessen these effects and lead to ozone increases. Reducing NO
                    <E T="52">X</E>
                     by a larger amount can, however, change the ozone chemistry from NO
                    <E T="52">X</E>
                    -saturated to NO
                    <E T="52">X</E>
                    -limited, meaning that NO
                    <E T="52">X</E>
                     emission reductions can again result in reduced ozone. The overall effect of NO
                    <E T="52">X</E>
                     emissions on an area's ozone chemistry depends on the location's existing mix of ozone and VOCs, as well as the location relative to the source of NO
                    <E T="52">X</E>
                     emissions.
                </P>
                <HD SOURCE="HD2">B. Response to Comments</HD>
                <P>
                    <E T="03">Comment #1:</E>
                     CBD notes that CAA section 182(c)(2)(C) allows a state to substitute NO
                    <E T="52">X</E>
                     emissions reductions for the VOC reductions otherwise required by CAA section 182(c)(2)(B) (“NO
                    <E T="52">X</E>
                     substitution”) if it demonstrates that the combined VOC and NO
                    <E T="52">X</E>
                     reductions “would result in a reduction in ozone concentrations at least equivalent” to the reduction in ozone concentrations achieved through VOC emissions reductions alone. CBD argues that CAA section 182(c)(2)(C)'s use of the plural “ozone concentrations” means that an equivalency demonstration at a single monitoring site would be insufficient, and therefore asserts that Congress intended the equivalence requirement to apply throughout the nonattainment area. CBD interprets statements in the proposal that the Sacramento Metro Area is NO
                    <E T="52">X</E>
                    -limited to indicate that the EPA agrees that equivalence must be demonstrated throughout the nonattainment area and says that the EPA must confirm this understanding in a final rule.
                    <PRTPAGE P="58585"/>
                </P>
                <P>
                    <E T="03">Response to Comment #1:</E>
                     The EPA disagrees that CAA section 182(c)(2)(C)'s use of the term “ozone concentrations” warrants the commenter's narrow interpretation that equivalence must be specifically demonstrated throughout a nonattainment area. As an initial matter, we note that the Act commonly uses the term “concentrations” to refer generally to ambient pollution levels at one or more (but not necessarily multiple) monitors or locations.
                    <SU>27</SU>
                    <FTREF/>
                     Moreover, CAA section 182(c)(2)(C) grants the EPA discretion to define the conditions under which NO
                    <E T="52">X</E>
                     reductions may be substituted for or combined with VOC reductions “in order to maximize the reduction in ozone air pollution” and does not further specify the conditions that represent an “equivalent” reduction in ozone; for instance, it does not require a specific concentration test at every monitor or at specific locations within an area. No such requirement appears in the Act's other provisions governing the RFP demonstration, which define specific percentage reductions aimed at ensuring timely attainment of the NAAQS,
                    <SU>28</SU>
                    <FTREF/>
                     or in the EPA's 1993 NO
                    <E T="52">X</E>
                     Substitution Guidance, which describes a recommended procedure for states to utilize NO
                    <E T="52">X</E>
                     substitution.
                    <SU>29</SU>
                    <FTREF/>
                     We interpret CAA 182(c)(2)(C) and these supporting authorities as properly reflecting Congress' intent to allow NO
                    <E T="52">X</E>
                     reductions to be considered within an RFP demonstration so long as these reductions are at least as effective in reducing ozone consistent with the area's demonstration of timely attainment.
                    <SU>30</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         
                        <E T="03">E.g.,</E>
                         CAA section 107(e)(2); CAA section 110(a)(5)(D).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         
                        <E T="03">E.g.,</E>
                         CAA 182(b)(1) and (c)(2)(B); see also CAA 171(1) (defining RFP as “such annual incremental reductions in emissions of the relevant air pollutant as are required by this part or may reasonably be required by the Administrator for the purpose of ensuring attainment of the applicable national ambient air quality standard by the applicable date”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         NO
                        <E T="52">X</E>
                         Substitution Guidance, Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, December 1993, available at 
                        <E T="03">https://archive.epa.gov/ttn/ozone/web/html/index-13.html.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         See id. at 8, (quoting H. Rept. No. 490, 101st Cong., 2d Sess. 239 (1990)), (“NO
                        <E T="52">X</E>
                         reductions may not be substituted for VOC reductions in a manner that delays attainment of the ozone standard or that results in lesser annual reductions in ozone concentration than provided for in the attainment demonstration.”).
                    </P>
                </FTNT>
                <P>
                    Also, we disagree with the commenter's assertion that statements from the proposed rule describing the Sacramento Metro Area as NO
                    <E T="52">X</E>
                    -limited convey the EPA's position that NO
                    <E T="52">X</E>
                     substitution requires a specific demonstration of equivalence throughout all portions or monitors within a nonattainment area. As described in our proposed rule and discussed further in our responses below, NO
                    <E T="52">X</E>
                    -limited conditions likely persist throughout the Sacramento Metro Area, suggesting that NO
                    <E T="52">X</E>
                     reductions will generally be effective in reducing ozone concentrations; with these statements, we intended no other suggestion regarding the demonstration necessary to support NO
                    <E T="52">X</E>
                     substitution. The EPA evaluates the appropriateness of NO
                    <E T="52">X</E>
                     substitution on a case-by-case basis,
                    <SU>31</SU>
                    <FTREF/>
                     considering the balance of available evidence to support the efficacy of NO
                    <E T="52">X</E>
                     reductions in reducing ambient ozone concentrations as necessary for timely attainment, and consistent with the requirements of CAA section 182(c)(2)(C).
                </P>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         NO
                        <E T="52">X</E>
                         Substitution Guidance at 3 (“The EPA will approve substitution proposals on a case-by-case basis. Generally speaking, any reasonable substitution proposal will be approved.”); also, id. at 1 (explaining that the Guidance's purpose is “to provide 
                        <E T="03">a</E>
                         procedure that can be applied to meet the post-1996 Section 182(c)(2)(B) RFP requirement as well as the Section 182(c)(2)(C) equivalency demonstration requirements” (emphasis in original).
                    </P>
                </FTNT>
                <P>
                    In some areas, NO
                    <E T="52">X</E>
                     emissions reductions may be needed for attainment, even though it may not be possible to decrease ozone concentrations simultaneously at all locations in the short term. For example, in some NO
                    <E T="52">X</E>
                    -limited areas, reducing NO
                    <E T="52">X</E>
                     emissions may represent the most effective or only approach to timely attainment, but may nonetheless generate temporary ozone increases in some locations due to NO
                    <E T="52">X</E>
                     titration or local NO
                    <E T="52">X</E>
                    -saturated conditions. In these areas, we believe it is reasonable to implement NO
                    <E T="52">X</E>
                     reductions in lieu of some portion of the VOC emissions reductions otherwise required for RFP as part of an area's strategy for timely NAAQS attainment and notwithstanding limited short-term increases, as an alternative to pursuing relatively ineffective VOC controls. We discuss conditions for the Sacramento Metro Area in detail below, including the relative importance and efficacy of NO
                    <E T="52">X</E>
                     reductions for attainment.
                </P>
                <P>
                    <E T="03">Comment #2:</E>
                     CBD comments that the Plan's evidence is equivocal and insufficient to show that NO
                    <E T="52">X</E>
                     substitution will result in equivalent reductions in ozone concentrations throughout the nonattainment area. According to the commenter, the Plan's analysis of the “weekend effect” in the years 2000-2014 shows a shift to more NO
                    <E T="52">X</E>
                    -saturated conditions in the Western and Central subregions of the Sacramento Metro Area and more transitional conditions in the Eastern region, and this is not inconsistent with the independent study of conditions in the years 2001-2007 cited by the EPA. CBD says that this evidence is insufficient for the EPA to rationally conclude that the entire nonattainment area is currently NO
                    <E T="52">X</E>
                    -limited, and that, at most, it can only be concluded that the Eastern region is still NO
                    <E T="52">X</E>
                    -limited. Furthermore, CBD says that the EPA must consider changes in NO
                    <E T="52">X</E>
                     emissions occuring by 2024, such as the replacement of natural gas power plants by less NO
                    <E T="52">X</E>
                    -emitting sources, to determine whether the entire Sacramento Metro Area will be NO
                    <E T="52">X</E>
                    -limited through 2024.
                </P>
                <P>
                    The commenter characterizes the Plan's evidence as qualitative, rather than quantitative. The commenter states that a qualitative analysis does not address the possibility that NO
                    <E T="52">X</E>
                     reductions could change the characteristics of the area and argues that the definition of the word “equivalent” as used in CAA section 182(c)(2)(C) requires a quantitative analysis, such as photochemical grid modeling. The commenter notes that the Plan uses photochemical grid modeling to analyze ozone sensitivity to NO
                    <E T="52">X</E>
                     reductions in the context of the attainment demonstration. CBD then states that this modeling analysis is insufficient to support the Plan's conclusion that the entire area is NO
                    <E T="52">X</E>
                    -limited or to show equivalence throughout the nonattainment area because the Plan includes one isopleth diagram only for the Folsom monitoring site in the Eastern subregion.
                    <SU>32</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         An “isopleth” is a line connecting points having the same value of a quantity, such as ozone concentration. Ozone isopleth diagrams typically have a series of such lines to show the ozone concentration for any combination of NO
                        <E T="52">X</E>
                         and VOC emissions, just as contour lines on a map show the elevation for any combination of latitude and longitude.
                    </P>
                </FTNT>
                <P>
                    According to the commenter, approving NO
                    <E T="52">X</E>
                     substitution based on a demonstration of equivalence at only one monitor or subregion is arbitrary for two reasons, even if it does not cause other monitors to exceed the 2008 ozone NAAQS. First, it may cause, or interfere with resolving, violations of the more protective 2015 ozone NAAQS in NO
                    <E T="52">X</E>
                    -saturated areas (which the commenter says would violate CAA section 110(l)). Second, increased ozone levels, even below the NAAQS, may still result in injury to public health and welfare.
                </P>
                <P>
                    <E T="03">Response to Comment #2:</E>
                     The EPA disagrees that the Plan's evidence is insufficient to support the use of NO
                    <E T="52">X</E>
                     substitution under CAA section 182(c)(2)(C). As discussed in our response to Comment 1, use of NO
                    <E T="52">X</E>
                      
                    <PRTPAGE P="58586"/>
                    substitution within an RFP demonstration does not require establishing equivalent reductions in ozone concentrations throughout the nonattainment area. As discussed in detail below, the Plan shows that, overall, the area has transitioned from NO
                    <E T="52">X</E>
                    -saturated to NO
                    <E T="52">X</E>
                    -limited as NO
                    <E T="52">X</E>
                     emissions have declined, and that NO
                    <E T="52">X</E>
                     reductions are more effective than VOC reductions on a percentage basis. Consistent with these conditions, the Sacramento Metro Area has relied on, and continues to rely on, NO
                    <E T="52">X</E>
                     reductions to demonstrate attainment. While decreases in ozone concentrations may have been delayed initially at some locations because of the location-specific and complex behavior of NO
                    <E T="52">X</E>
                     in ozone formation, Sacramento Metro Area ozone design values have shown a general downward trend at all monitors from 1990 to the present, demonstrating that these locations have not experienced the increased ozone design values of concern to the commenter, and that the Plan demonstrates timely attainment of the NAAQS at all locations. For these reasons and as addressed below, we find that the Plan provides adequate evidence and justification for its use of NO
                    <E T="52">X</E>
                     substitution.
                </P>
                <P>
                    As we discussed in the proposed rule and our accompanying technical support document, the State concludes that NO
                    <E T="52">X</E>
                     reductions are more effective than VOC reductions throughout the Sacramento Metro Area.
                    <SU>33</SU>
                    <FTREF/>
                     The State supports this conclusion with modeling and monitoring of weekday-weekend differences in ozone formation and citations to published research papers that study these differences and the response to NO
                    <E T="52">X</E>
                     reductions in detail, as described below. The State estimates weekday-weekend differences in ozone concentrations using the Community Multiscale Air Quality (CMAQ) photochemical model as part of the air quality model's performance evaluation for the 2012 base year, in conjunction with the attainment demonstration. As described in the Plan, in the early 2000's the western region of the Sacramento Metro Area exhibited a “weekend effect,” in which weekend ozone concentrations were higher despite having lower NO
                    <E T="52">X</E>
                     emissions, suggesting a NO
                    <E T="52">X</E>
                     disbenefit at that time.
                    <SU>34</SU>
                    <FTREF/>
                     The modeling results in the Plan show that the average daily maximum ozone concentrations at all monitoring sites are higher on weekdays, indicating that maximum ozone concentrations are lower when NO
                    <E T="52">X</E>
                     emissions are lower, and that peak ozone formation is NO
                    <E T="52">X</E>
                    -limited, at all monitoring sites. This is illustrated in Figure 14 from Appendix B-4 of the 2017 Sacramento Regional Ozone Plan, which shows average modeled 2012 weekday-weekend ozone concentrations above a 1:1 line, 
                    <E T="03">i.e.,</E>
                     higher weekday concentrations, for all monitoring sites in each subregion in the nonattainment area (Western, Central, and Eastern).
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         85 FR 68509, 68520 (October 29, 2020); “Modeling TSD—2017 Sacramento Regional Ozone Plan,” September 14, 2020, Air and Radiation Division, EPA Region IX, 25-26.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         2017 Sacramento Regional Ozone Plan, Appendix B-4, B-148; CARB Staff Report B-33.
                    </P>
                </FTNT>
                <P>
                    In addition, the modeled differences in ozone concentrations are generally consistent with the monitored ambient concentrations.
                    <SU>35</SU>
                    <FTREF/>
                     Monitored ozone concentrations included in the Plan for each year from 2000 to 2014 generally progressed from a NO
                    <E T="52">X</E>
                     disbenefit, 
                    <E T="03">i.e.,</E>
                     higher weekend concentrations, to a NO
                    <E T="52">X</E>
                    -limited or transitional regime, 
                    <E T="03">i.e.,</E>
                     weekend concentrations lower than or about the same as weekday concentrations.
                    <SU>36</SU>
                    <FTREF/>
                     The Eastern subregion has shown higher concentration on weekdays than on weekends for the entire period, 
                    <E T="03">i.e.,</E>
                     no “weekend effect”; this is evidence that ozone formation is NO
                    <E T="52">X</E>
                    -limited there. By 2014, the Western and Central subregions of the Sacramento Metro Area show nearly identical weekday and weekend concentrations, suggesting these areas had shifted to a transitional regime by that time.
                    <SU>37</SU>
                    <FTREF/>
                     For the Western subregion, the Plan notes that the shift toward transitional conditions occurred at ozone levels under 50 parts per billion (ppb), well below the 2008 ozone NAAQS of 75 ppb, meaning that these changes are not leading to NAAQS exceedances. Indeed, monitoring sites in the Western subregion have met the 75 ppb NAAQS from 2011 to the present day. Within the Central subregion, ambient ozone data recorded for 2011-2014 show ozone levels under 70 ppb.
                    <SU>38</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         2017 Sacramento Regional Ozone Plan, Appendix B-4, B-149, Figure 14. For sites appearing just above the 1:1 line, modeled weekday ozone is higher by only a small amount.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         Id.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         Id. The commenter has interpreted the presence of points below the 1:1 line as evidence of NO
                        <E T="52">X</E>
                        -saturated ozone formation, but that interpretation would be supported only by points much farther below the line.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         2017 Sacramento Regional Ozone Plan, Appendix B-4, B-148.
                    </P>
                </FTNT>
                <P>
                    The Plan suggests that the shift to a transitional regime could be explained by natural year-to-year variability in biogenic VOC emissions and in local meteorology.
                    <SU>39</SU>
                    <FTREF/>
                     This is consistent with the relatively low level of biogenic VOC emissions during 2011-2014,
                    <SU>40</SU>
                    <FTREF/>
                     which would decrease the VOC:NO
                    <E T="52">X</E>
                     ratio and shift the atmosphere toward a transitional ozone formation regime (though not necessarily all the way to NO
                    <E T="52">X</E>
                     saturation). VOC emissions have also decreased steadily from 2000 to the present day,
                    <SU>41</SU>
                    <FTREF/>
                     and biogenic VOC emissions in the Sacramento Metro Area, while variable, are about ten times higher than those from anthropogenic sources.
                    <SU>42</SU>
                    <FTREF/>
                     Accordingly, the shift to smaller differences in weekday-weekend ozone concentrations seen in 2014 could be the result of natural variability in biogenic VOC emissions that causes some locations to be transitional or NO
                    <E T="52">X</E>
                    -saturated on some days.
                </P>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         Id.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         2017 Sacramento Regional Ozone Plan Appendix B-2, B-31 and B-34.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         CARB Staff Report, B-16.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         CARB Staff Report, B-7.
                    </P>
                </FTNT>
                <P>
                    The Plan also suggests variability in meteorology as a factor in shifting ozone chemistry between NO
                    <E T="52">X</E>
                    -limited and NO
                    <E T="52">X</E>
                    -disbenefit regimes.
                    <SU>43</SU>
                    <FTREF/>
                     The Plan cites a research paper that examined the effect of temperature and found that “the average O
                    <E T="52">3</E>
                     is higher on weekends than on weekdays only for the lowest temperature days.” 
                    <SU>44</SU>
                    <FTREF/>
                     Natural annual variability also applies to the degree of pollutant carryover from one day to the next day; day-to-day carryover can mix weekday and weekend pollutants, making weekdays and weekends appear to be more similar. In addition, the NO
                    <E T="52">X</E>
                     emissions reductions that have occurred from 2000 to the present day have decreased the difference between weekday and weekend NO
                    <E T="52">X</E>
                     emissions, which would also decrease the differences in weekday and weekend ozone concentrations.
                </P>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         2017 Sacramento Regional Ozone Plan Appendix B-4, B-148.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         LaFranchi, B.W., Goldstein, A.H., and Cohen, R.C., 2011, “Observations of the temperature dependent response of ozone to NO
                        <E T="52">X</E>
                         reductions in the Sacramento, CA urban plume,” 
                        <E T="03">Atmospheric Chemistry and Physics,</E>
                         11, 6945-6960, 
                        <E T="03">https://doi.org/10.5194/acp-11-6945-2011,</E>
                         6954 (“LaFranchi et al. 2011”).
                    </P>
                </FTNT>
                <P>
                    Although these plots of weekday-weekend ozone differences provide a useful indicator, they are not a definitive description of the ozone chemistry involved. The plots show only the resulting ozone concentrations, not any ozone precursors or meteorology whose interaction results in those concentrations. Furthermore, the weekday-weekend plots show just a single point for each monitor-year combination, the average over a year's summer days of daily maximum 8-hour ozone concentrations, rather than a point for each day. Ozone concentrations vary between the days of 
                    <PRTPAGE P="58587"/>
                    a single year, not just between years. A data point near the 1:1 line may indicate that weekday-weekend differences are small due to transitional chemistry on every individual day. Alternatively, it could indicate that positive differences balance out negative ones, due to a mix of high-ozone NO
                    <E T="52">X</E>
                    -limited days and low-ozone NO
                    <E T="52">X</E>
                    -saturated or transitional days. This would mean that NO
                    <E T="52">X</E>
                    -saturated days with lower ozone concentrations and less regulatory and health significance would be masking NO
                    <E T="52">X</E>
                    -limited days with higher ozone concentrations and greater significance. In the context of the analyses and evidence presented in the Plan, the smaller weekday-weekend differences in ozone concentrations in 2014 do not indicate a change in ozone chemistry that would suggest a control strategy failure or an unknown phenomenon. As the State explains, variability in biogenic VOC emissions and in meteorology provide an explanation for some locations being transitional or NO
                    <E T="52">X</E>
                    -saturated on some days. We agree with the State that the weekday-weekend analyses support the conclusion that ozone formation in the Sacramento Metro Area is mainly in a NO
                    <E T="52">X</E>
                    -limited regime, with some periods in a NO
                    <E T="52">X</E>
                    -transitional regime, and that there is no disbenefit from NO
                    <E T="52">X</E>
                     controls. Next, we review and present additional research evidence from the Plan that further supports our conclusion that the Sacramento Metro Area's ozone chemistry is NO
                    <E T="52">X</E>
                    -limited.
                </P>
                <P>
                    To supplement the analysis of weekday-weekend conditions, the Plan cites several research and analysis papers examining daily and hourly concentrations of ozone, NO
                    <E T="52">X</E>
                    , and VOC in the years prior to 2011, which support the conclusion that ozone formation in the Sacramento area is currently NO
                    <E T="52">X</E>
                    -limited. Two related papers by Murphy et al., from 2006 and 2007, examine monitored data from 1998-2002 for the Central and Eastern subregions of the Sacramento Metro Area.
                    <SU>45</SU>
                    <FTREF/>
                     As described in these papers, the “weekend effect,” 
                    <E T="03">i.e.,</E>
                     conditions in which ozone concentrations are higher on weekends, was observed for monitoring sites in the Sacramento Valley (corresponding to the Central subregion).
                    <SU>46</SU>
                    <FTREF/>
                     The researchers attributed this largely to NO
                    <E T="52">X</E>
                     titration from mobile source emissions in urban Sacramento.
                    <SU>47</SU>
                    <FTREF/>
                     For the Mountain Counties of the Eastern subregion, the researchers found that weekday ozone concentrations were higher, consistent with NO
                    <E T="52">X</E>
                    -limited conditions.
                    <SU>48</SU>
                    <FTREF/>
                     The researchers' analysis suggests that under conditions of high concentrations of ozone and precursors flowing in from other urban areas, NO
                    <E T="52">X</E>
                     emission reductions of 50 percent or more would be needed to guarantee lower rates of ozone production in the Sacramento Valley portions studied, corresponding to the Central and Eastern subregions.
                    <SU>49</SU>
                    <FTREF/>
                     In comparison to this prospective analysis, NO
                    <E T="52">X</E>
                     emissions in the Sacramento Metro Area have decreased by 58 percent between 2000 and 2015. Thus, the work of Murphy et. al., along with subsequent NO
                    <E T="52">X</E>
                     emissions reductions, suggest that the full Sacramento Metro Area should currently be NO
                    <E T="52">X</E>
                    -limited.
                </P>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         Murphy, J.G., Day, D.A., Cleary, P.A., Wooldridge, P.J., Millet, D.B., Goldstein, A.H., and Cohen, R.C., 2007, “The weekend effect within and downwind of Sacramento—Part 1: Observations of ozone, nitrogen oxides, and VOC reactivity,” 
                        <E T="03">Atmos. Chem. Phys.,</E>
                         7, 5327-5339, 
                        <E T="03">https://doi.org/10.5194/acp-7-5327-2007</E>
                         (“Murphy et al. 2007”); Murphy, J.G., Day, D.A., Cleary, P.A., Wooldridge, P.J., Millet, D.B., Goldstein, A.H., and Cohen, R.C., 2006, “The weekend effect within and downwind of Sacramento: Part 2. Observational evidence for chemical and dynamical contributions,” 
                        <E T="03">Atmos. Chem. Phys. Discuss.,</E>
                         6, 11971-12019, 
                        <E T="03">https://doi.org/10.5194/acpd-6-11971-2006</E>
                         (“Murphy et al. 2006”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         Murphy et al., 2007 at 5332.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         Murphy et al., 2007 at 5336; Murphy et. al., 2006 at 11972.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>48</SU>
                         Murphy et al., 2007 at 5336.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         Murphy et al., 2006 at 11996.
                    </P>
                </FTNT>
                <P>
                    LaFranchi et al., 2011 examines monitored data from 2001-2007 for the Central and Eastern subregions.
                    <SU>50</SU>
                    <FTREF/>
                     These researchers found NO
                    <E T="52">X</E>
                    -saturated conditions in the urban core, but mainly at lower temperatures and lower ozone concentrations, and determined that NO
                    <E T="52">X</E>
                     emissions reductions were effective at reducing maximum ozone concentrations.
                    <SU>51</SU>
                    <FTREF/>
                     The researchers also found no evidence that NO
                    <E T="52">X</E>
                     reductions have been detrimental to air quality. For example, the researchers found that the 30 percent decrease in NO
                    <E T="52">X</E>
                     and other nitrogen photochemical products from 2001 to 2007 was “extremely effective in reducing the exceedance probability at all locations during the hottest days of the year” when increases in biogenic emissions result in more NO
                    <E T="52">X</E>
                    -limited conditions.
                    <SU>52</SU>
                    <FTREF/>
                     Furthermore, the researchers note that:
                </P>
                <FTNT>
                    <P>
                        <SU>50</SU>
                         LaFranchi et al., 2011 at 6945-6960.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>51</SU>
                         Id. at 6954.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>52</SU>
                         Id.
                    </P>
                </FTNT>
                <EXTRACT>
                    <P>
                        It has been argued . . . that NO
                        <E T="52">X</E>
                         decreases cause O
                        <E T="52">3</E>
                         increases in the center of cities and are more detrimental to health because of the larger number of people who live in the urban core as opposed to the surrounding suburbs and rural regions. . . . We find that between 2001 and 2007, the average O
                        <E T="52">3</E>
                         is higher on weekends than on weekdays only for the lowest temperature days . . . well below the exceedance limit [California 1-hour standard of 90 ppb], increases in O
                        <E T="52">3</E>
                         with decreasing NO
                        <E T="52">X</E>
                         are not likely to lead to additional exceedances. Thus, we find no evidence that implementation of NO
                        <E T="52">X</E>
                         emission controls has been detrimental to air quality, by any policy-relevant metric.
                        <SU>53</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>53</SU>
                             Id. at 6954-6955.
                        </P>
                    </FTNT>
                </EXTRACT>
                <P>
                    Since NO
                    <E T="52">X</E>
                     emissions examined in the Plan and today are now lower 
                    <SU>54</SU>
                    <FTREF/>
                     than during the periods examined in these research papers, ozone formation is now expected to be within a more NO
                    <E T="52">X</E>
                    -limited regime. As a result, current conditions are consistent with and fit the predictions in LaFranchi et al., that NO
                    <E T="52">X</E>
                     emissions reductions decrease ozone concentrations in the Eastern subregion and more recently in the Central subregion; the possible exception being when ozone levels are already low, 
                    <E T="03">i.e.,</E>
                     well below the 2008 NAAQS.
                </P>
                <FTNT>
                    <P>
                        <SU>54</SU>
                         Anthropogenic VOC emissions have also decreased, but because biogenic emissions are so much greater, the overall effect of the NO
                        <E T="52">X</E>
                         and VOC reductions has been to increase the VOC/NO
                        <E T="52">X</E>
                         ratio, resulting in more NO
                        <E T="52">X</E>
                        -limited ozone chemistry.
                    </P>
                </FTNT>
                <P>
                    Overall, the State's evidence presented in the Plan suggests that NO
                    <E T="52">X</E>
                     reductions are more effective than VOC reductions at decreasing ozone concentrations in the Sacramento Metro Area. For example, LaFranchi et al., observe that “the intensity of biogenic VOC emissions have made NO
                    <E T="52">X</E>
                     emission reductions more effective than anthropogenic VOC emission reductions in the region, at least downwind of Del Paso [
                    <E T="03">i.e.,</E>
                     within the Central and Eastern subregions].” 
                    <SU>55</SU>
                    <FTREF/>
                     The Plan's ozone isopleth diagram for the Folsom monitor 
                    <SU>56</SU>
                    <FTREF/>
                     also provides strong evidence that NO
                    <E T="52">X</E>
                     emission reductions are more effective than VOC reductions. The State generated this diagram using photochemical grid modeling to simulate various combinations of NO
                    <E T="52">X</E>
                     and VOC emissions reductions and plotting the resulting ozone concentrations for the Folsom monitor, the ambient ozone monitor with the highest ozone design value in the Sacramento Metro Area. The diagram shows a nearly horizontal slope of the isopleth lines, indicating that ozone formation in the Folsom area is much more responsive to NO
                    <E T="52">X</E>
                     emission reductions than to VOC reductions.
                    <SU>57</SU>
                    <FTREF/>
                     As discussed in the proposed rule for this action, the EPA estimated from the ozone isopleth diagram in the Plan that ozone formation is about 14 times as 
                    <PRTPAGE P="58588"/>
                    sensitive to NO
                    <E T="52">X</E>
                     reductions than to VOC reductions on a percentage basis, and about 24 times as sensitive on a tons-per-year basis.
                    <SU>58</SU>
                    <FTREF/>
                     Because the Plan demonstrates a shift to NO
                    <E T="52">X</E>
                    -limited conditions throughout all subregions in the area through its review of relevant research and includes additional modeling evidence at the Folsom monitor to support the Plan's reliance on NO
                    <E T="52">X</E>
                     emissions reductions to achieve attainment, we disagree with CBD that additional evidence is needed to support the use of NO
                    <E T="52">X</E>
                     substitution under CAA section 182(c)(2)(C).
                </P>
                <FTNT>
                    <P>
                        <SU>55</SU>
                         LaFranchi et al. 2011 at 6958. Id. at 6946-6947, which notes that VOC reactivity is controlled primarily by biogenic emissions, including the urban core. This suggests that reducing anthropogenic VOC emissions may be relatively ineffective for reducing ozone.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>56</SU>
                         2017 Sacramento Regional Ozone Plan Appendix B-4, B-158, Figure 16.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>57</SU>
                         Id.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>58</SU>
                         85 FR 68509, 68522 (October 29, 2020).
                    </P>
                </FTNT>
                <P>
                    We also disagree with the commenter's assertion that our proposed approval does not consider emissions changes through 2024. The Folsom isopleth diagram that supports the Plan's comparison of pre-2015 monitored weekday-weekend data shows that NO
                    <E T="52">X</E>
                     reductions are far more effective than VOC emissions based on 2026 emissions and including changes through and after 2024.
                    <SU>59</SU>
                    <FTREF/>
                     Furthermore, the changes in emissions through 2024 posited by the commenter would not alter the EPA's conclusion that NO
                    <E T="52">X</E>
                     substitution is appropriate. Indeed, we anticipate that the replacement of NO
                    <E T="52">X</E>
                     combustion sources with wind and solar electricity generation, as well as continuing mobile source NO
                    <E T="52">X</E>
                     reductions through 2024 and beyond, will make the Sacramento Metro Area even more NO
                    <E T="52">X</E>
                    -limited, thereby further strengthening the Plan's conclusions regarding the efficacy of NO
                    <E T="52">X</E>
                     emissions reductions compared to VOC reductions.
                </P>
                <FTNT>
                    <P>
                        <SU>59</SU>
                         Plan Appendix B-4, B-158.
                    </P>
                </FTNT>
                <P>
                    The EPA also disagrees that an equivalence demonstration requires a quantitative analysis. Depending on the facts and circumstances of a given nonattainment area, analytical information that establishes equivalence may be quantitative or qualitative, or both. In this instance, some of the evidence relied upon could be termed qualitative, such as the shape of curves in the isopleth diagram.
                    <SU>60</SU>
                    <FTREF/>
                     The Plan's modeling and monitoring analyses, and the analyses used in the cited research papers, are predominantly quantitative, with qualitative aspects and some qualitative conclusions. Qualitative evidence can be just as useful as quantitative evidence. For NO
                    <E T="52">X</E>
                     substitution to yield an equivalent ozone decrease, as required in CAA section 182(c)(2)(C), a demonstration is adequate if it shows that NO
                    <E T="52">X</E>
                     reductions are more effective than VOC reductions—it does not need to quantify an exact amount by which these reductions are more effective.
                </P>
                <FTNT>
                    <P>
                        <SU>60</SU>
                         These curves are partly quantified by the proposed rule's estimate that NO
                        <E T="52">X</E>
                         emissions reductions are 14 times as effective as VOC reductions.
                    </P>
                </FTNT>
                <P>
                    We also disagree with CBD's suggestion that the overall geographic distribution of NO
                    <E T="52">X</E>
                     and VOC emissions would be significantly affected by realistic and incremental changes in these emissions. Incremental changes resulting from the construction or closing of NO
                    <E T="52">X</E>
                     point sources would not affect the preponderance of NO
                    <E T="52">X</E>
                     emissions from mobile sources in the developed urban area, when compared to the lower NO
                    <E T="52">X</E>
                     emissions in suburban and rural areas. These changes would also not significantly affect the reverse pattern of relatively more VOC emissions (from biogenic sources) in rural areas compared to urban areas. Such small changes in overall NO
                    <E T="52">X</E>
                     or VOC emissions would merely affect the degree and amount by which NO
                    <E T="52">X</E>
                     reductions are shown to be more effective than VOC reductions. Consequently, the EPA's overall conclusion that NO
                    <E T="52">X</E>
                     substitution within the Plan meets the requirements of CAA section 182(c)(2)(C) remains unchanged.
                </P>
                <P>
                    Regarding CBD's concern that ambient ozone data from a single monitoring site is inadequate to demonstrate equivalency, we agree that this could be problematic in some circumstances but disagree that this is a problem for the Sacramento Metro Area, for two reasons. First, as discussed previously, in concluding that NO
                    <E T="52">X</E>
                     emissions reductions are more effective than VOC reductions at reducing ozone, the State considered studies of ozone response at monitoring sites throughout the nonattainment area as part of the Plan. Second, the Plan demonstrates attainment at all monitoring sites, and its conclusion that NO
                    <E T="52">X</E>
                     reductions are more effective than VOC for the site with the highest design value, 
                    <E T="03">i.e.,</E>
                     the Folsom monitoring site, the “controlling” site for determining whether or not the NAAQS is attained in the Sacramento Metro Area, therefore ensures that NO
                    <E T="52">X</E>
                     reductions will be effective in achieving ozone reductions that will help the nonattainment area toward attainment in all sub-regions. We anticipate that any increase in ozone concentrations that might result from NO
                    <E T="52">X</E>
                     emission reductions would be only small, transient, and affect locations with ozone concentrations well below the NAAQS. These ozone increases would typically occur under low temperature conditions, with corresponding low ozone concentrations well below the NAAQS, not at elevated ozone concentrations that could affect public health or interfere with attainment of the 2015 ozone NAAQS. As noted above, ambient ozone data recorded in the Central subregion of the Sacramento Metro Area between 2011 and 2014 already show ozone levels under 70 ppb, the concentration that the EPA has established as the 2015 ozone NAAQS.
                </P>
                <P>
                    Concerning future air quality planning for the 2015 ozone NAAQS, the State has requested that the EPA reclassify the Sacramento Metro nonattainment area as a Serious nonattainment area, and the attainment plan for Serious areas is not yet due. The EPA has proposed to require that the State submit an attainment plan for the 2015 ozone NAAQS for the Sacramento Metro Area by August 3, 2022.
                    <SU>61</SU>
                    <FTREF/>
                     As proposed, this plan will be required to demonstrate, through photochemical grid modeling and other demonstrations, that all portions of the Sacramento Metro Area will attain the 2015 NAAQS by no later than August 3, 2027. Based on conditions in this area as described above and in the proposed rule and the Plan, we anticipate that NO
                    <E T="52">X</E>
                     reductions, including those used to demonstrate attainment of the 2008 ozone NAAQS, will remain a critical piece of the State's control strategy to meet the 2015 ozone NAAQS. Accordingly, we disagree with CBD's assertion that the Plan's use of NO
                    <E T="52">X</E>
                     substitution will interfere with attainment of the newer and more stringent ozone standards in the Sacramento Metro Area or violate CAA section 110(l).
                </P>
                <FTNT>
                    <P>
                        <SU>61</SU>
                         86 FR 44677, 44678 (August 13, 2021).
                    </P>
                </FTNT>
                <P>
                    <E T="03">Comment #3:</E>
                     CBD states that an equivalence demonstration should be as rigorous as an attainment demonstration; as such, an equivalence demonstration should be based on photochemical modeling or another equally rigorous technique. The commenter suggests that the State could compare modeled relative response factors (RRFs) for each RFP milestone year for the 3 percent per year VOC reductions to corresponding RRFs from the control strategy, or the State could use ozone isopleth diagrams together with conservative assumptions about the amount of allowable NO
                    <E T="52">X</E>
                     substitution. The commenter acknowledges that section 182(c)(2)(C) does not explicitly prescribe the use of photochemical grid modeling or an equally rigorous method and argues that this does not mean that section 182(c)(2)(C) is worthy of a less rigorous demonstration. The commenter argues that Congress added the RFP provisions to the CAA in response to the EPA's failure to address ozone pollution under 
                    <PRTPAGE P="58589"/>
                    the general requirements for attainment demonstrations in subpart 1 of the CAA. The commenter states that, in any case, it would be arbitrary for the EPA to ignore the entire nonattainment area except for the isopleths at the Folsom monitor and the Eastern region weekend effect in assessing the equivalence demonstration.
                </P>
                <P>
                    <E T="03">Response to Comment #3:</E>
                     The EPA disagrees that an equivalence demonstration for purposes of CAA section 182(c)(2)(C) must be as technically rigorous as a NAAQS attainment demonstration. As the commenter notes, CAA section 182(c)(2)(C) does not require the use of photochemical grid modeling to demonstrate the relative effectiveness of NO
                    <E T="52">X</E>
                     and VOC emissions reductions in reducing ozone concentrations, whereas CAA section 182(c)(2)(A) explicitly requires photochemical grid modeling or another equivalent analytical method as part of the attainment demonstration. Instead, Congress provided the EPA with discretion to evaluate state demonstrations supporting NO
                    <E T="52">X</E>
                     substitution, and to define the conditions under which NO
                    <E T="52">X</E>
                     substitution is appropriate “in order to maximize the reduction in ozone air pollution.” 
                    <SU>62</SU>
                    <FTREF/>
                     We believe that this approach reflects an appropriate balance in the level of analysis required for demonstrating attainment by the attainment date, and for the supporting evaluation of the relative effectiveness of potential measures and reductions used to meet RFP milestones. Consequently, we disagree that a NO
                    <E T="52">X</E>
                     equivalence demonstration for RFP purposes must reflect the same or equally rigorous analytical methods as used in the attainment demonstration. As discussed previously, a qualitative analysis may show that NO
                    <E T="52">X</E>
                     reductions are more effective than VOC reductions and be adequate for purposes of allowing NO
                    <E T="52">X</E>
                     substitution under section 182(c)(2)(C). As described above, we proposed to approve the RFP demonstration and its use of NO
                    <E T="52">X</E>
                     substitution based on our analyses of the photochemical modeling results included in the attainment demonstration and the Folsom isopleth diagram, the other monitoring data from the Plan, and the research papers and analyses cited within. Collectively, these analyses and data show that NO
                    <E T="52">X</E>
                     emissions reductions are effective at reducing ozone throughout the Sacramento Metro Area and are more effective than VOC reductions at bringing the area into attainment of the NAAQS. Accordingly, we support the Plan's use of NO
                    <E T="52">X</E>
                     substitution.
                </P>
                <FTNT>
                    <P>
                        <SU>62</SU>
                         CAA section 182(c)(2)(C).
                    </P>
                </FTNT>
                <P>
                    <E T="03">Comment #4:</E>
                     CBD comments that the EPA has not demonstrated that the approval of NO
                    <E T="52">X</E>
                     substitution complies with Executive Order 12898, which expresses the EPA's obligation to identify and address disproportionate impacts of its actions on minority populations and low-income populations, 
                    <E T="03">i.e.,</E>
                     environmental justice (EJ) communities. The commenter asserts that because the EPA is not applying the NO
                    <E T="52">X</E>
                     Substitution Guidance in evaluating the Plan's use of NO
                    <E T="52">X</E>
                     substitution, it is exercising discretion, and should use this discretion to require the State to demonstrate equivalence at each monitoring site through photochemical modeling of the relevant scenarios. Furthermore, the commenter says that because the record does not support the EPA's conclusion that NO
                    <E T="52">X</E>
                     substitution will result in equivalent reductions in ozone concentrations throughout the area, EJ communities may be disproportionately and adversely impacted by the EPA's action by experiencing fewer reductions in ozone than would be achieved through VOC reductions alone, or even ozone increases. The commenter suggests that the EPA could exercise discretion to disapprove the Plan on this basis, and that this disapproval could result in the EPA issuing a Federal implementation plan requiring additional emissions reductions to ensure equivalent reductions in ozone concentrations. The commenter states that it is not a sufficient response to say that approving the Plan will have no adverse impact to EJ communities because it improves the status quo by making State law federally enforceable. The commenter provides a map generated using CalEnviroScreen, showing EJ communities concentrated in the Central subregion where the commenter asserts that the Plan does not demonstrate equivalence.
                </P>
                <P>
                    <E T="03">Response to Comment #4:</E>
                     As explained in our previous responses, the EPA and the State have determined that NO
                    <E T="52">X</E>
                     reductions are critical to the Sacramento Metro Area's attainment of the 2008 ozone NAAQS and we anticipate that any localized increase in ozone concentrations resulting from these NO
                    <E T="52">X</E>
                     reductions would be minor, transitory, and occur well below the limits established by the NAAQS. Furthermore, we find that the Plan appropriately focuses on ozone reductions in the regions subject to the highest ozone concentrations, 
                    <E T="03">e.g.,</E>
                     the eastern region and design value monitor at Folsom, where adverse health impacts are most likely to occur. In this context, we disagree that the use of NO
                    <E T="52">X</E>
                     substitution is inappropriate even if it may generate disproportionate reductions in ozone concentrations within high ozone and NO
                    <E T="52">X</E>
                    -limited areas.
                </P>
                <P>
                    Executive Order 12898, “Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations,” 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.
                    <SU>63</SU>
                    <FTREF/>
                     Given our conclusion that the Plan satisfies all applicable CAA requirements related to demonstrating expeditious attainment of the ozone NAAQS, including the requirements for RFP and NO
                    <E T="52">X</E>
                     substitution,
                    <SU>64</SU>
                    <FTREF/>
                     we have no basis to conclude that this action will cause disproportionately high or adverse human health or environmental effects on any population, including any minority, low-income, or indigenous population. Under the CAA, the EPA is required to approve a SIP submission that satisfies the requirements of the Act and applicable Federal regulations,
                    <SU>65</SU>
                    <FTREF/>
                     and Executive Order 12898 does not provide an independent basis for disapproving such a SIP submission. The EPA remains committed, however, to working with CARB and the local air districts in the Sacramento Metro Area to ensure that the ozone attainment plans for this area satisfy CAA requirements for attainment and RFP and thereby protect all populations in the area, including minority, low-income, and indigenous populations, from disproportionately high or adverse air pollution impacts.
                </P>
                <FTNT>
                    <P>
                        <SU>63</SU>
                         59 FR 7629 (February 16, 1994).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>64</SU>
                         Our response to Comment #7 discusses our reasons for deferring action on the State's contingency measures revision.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>65</SU>
                         CAA section 110(k); 40 CFR 52.02(a).
                    </P>
                </FTNT>
                <P>
                    <E T="03">Comment #5:</E>
                     CBD comments that the proposed rule fails to acknowledge the EPA's NO
                    <E T="52">X</E>
                     Substitution Guidance, and that the EPA should explicitly disavow the guidance and its justifications. The commenter says that there is no basis for this guidance and suggests that the EPA's prior use of the guidance may have caused increases in asthma, hospital and emergency room visits, and premature mortality. An appendix to the comments provides numerous comments directed at the NO
                    <E T="52">X</E>
                     Substitution Guidance, asserting generally that this guidance contradicts CAA section 182(c)(2)(C) by recommending a procedure that fails to 
                    <PRTPAGE P="58590"/>
                    demonstrate any equivalence between VOC and NO
                    <E T="52">X</E>
                     reductions, relies on incorrect policy assumptions, and gives legal justifications that are without merit.
                </P>
                <P>
                    <E T="03">Response to Comment #5:</E>
                     Our proposed approval of the Plan's use of NO
                    <E T="52">X</E>
                     substitution is compatible with the NO
                    <E T="52">X</E>
                     Substitution Guidance, which, while non-binding and not having the force of regulation, provides a recommended procedure for substituting NO
                    <E T="52">X</E>
                     emission reductions for VOC reductions on a percentage basis, consistent with a state's ozone attainment plan, control strategy, modeled attainment demonstration, and RFP milestones and requirements. The NO
                    <E T="52">X</E>
                     Substitution Guidance specifies that the EPA will review NO
                    <E T="52">X</E>
                     substitution on a case-by-case basis and will generally approve reasonable NO
                    <E T="52">X</E>
                     substitution proposals.
                    <SU>66</SU>
                    <FTREF/>
                     As noted in our proposed rule and described above, our approval of the State's reasonable use of NO
                    <E T="52">X</E>
                     substitution is supported by local conditions and needs as documented in the modeling and analyses included in the Sacramento Metro Ozone SIP and is consistent with the requirements in CAA section 182(c)(2)(C).
                    <SU>67</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>66</SU>
                         NO
                        <E T="52">X</E>
                         Substitution Guidance at 3 (“The EPA will approve substitution proposals on a case-by-case basis. Generally speaking, any reasonable substitution proposal will be approved.”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>67</SU>
                         See id. at 1 (recognizing that “NO
                        <E T="52">X</E>
                         controls may effectively reduce ozone in many areas, and that the design of strategies is more efficient when the characteristic properties responsible for ozone formation and control are evaluated for each area”).
                    </P>
                </FTNT>
                <P>
                    To be clear, our action on the Plan is not intended to disavow or rescind any portion of the NO
                    <E T="52">X</E>
                     Substitution Guidance. Comments relating solely to the NO
                    <E T="52">X</E>
                     Substitution Guidance are outside the scope of this rulemaking action.
                </P>
                <P>
                    <E T="03">Comment #6:</E>
                     CBD argues that, because the Plan does not meet the requirements for RFP, the EPA cannot determine that the MVEBs are allowable as a portion of the total allowable emissions for demonstrating RFP. The commenter asserts that because there is no measure of total allowable emissions for RFP in the absence of an approvable plan, the EPA has no basis for approval of the MVEBs.
                </P>
                <P>
                    <E T="03">Response to Comment #6:</E>
                     For the reasons described above in our previous responses to comments, we have determined that the State's use of NO
                    <E T="52">X</E>
                     substitution is appropriate and adequately supported within the Plan, consistent with the RFP and attainment demonstrations, and that the Plan's RFP demonstration is approvable. Consequently, we disagree with the commenter and their rationale suggesting that our approval of the MVEBs is inappropriate.
                </P>
                <P>
                    <E T="03">Comment #7:</E>
                     CBD challenges the EPA's proposed conditional approval of the contingency measures as arbitrary and capricious and contrary to law, based on CAA requirements and interpreting case law. The commenter asserts that the EPA must disapprove the contingency measures.
                </P>
                <P>
                    <E T="03">Response to Comment #7:</E>
                     As explained in the proposed rule, our proposed conditional approval of the State's RFP and attainment contingency measures was based on commitments from the State and Districts in the context of additional emissions reductions in the RFP milestone years and in the year following the attainment year. Following publication of the proposed rule, the Ninth Circuit Court of Appeals issued a decision in 
                    <E T="03">Association of Irritated Residents</E>
                     v. 
                    <E T="03">U.S. Environmental Protection Agency,</E>
                     which remanded the EPA's conditional approval of contingency measures for another California nonattainment area.
                    <SU>68</SU>
                    <FTREF/>
                     Based on this decision, we are not finalizing our proposed conditional approval of the Plan's contingency measures at this time. Consequently, CBD's comments on this issue are outside the scope of this final action and we are not providing specific responses to these comments.
                </P>
                <FTNT>
                    <P>
                        <SU>68</SU>
                         
                        <E T="03">Association of Irritated Residents</E>
                         v. 
                        <E T="03">U.S. Environmental Protection Agency,</E>
                         No. 19-71223 (9th Cir. Aug. 26, 2021).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">III. Final Action</HD>
                <P>For the reasons discussed in detail in the proposed rule and summarized herein, under CAA section 110(k)(3), the EPA is taking final action to approve as a revision to the California SIP the following portions of the Sacramento Metro Area Ozone SIP, as provided within the 2017 Sacramento Regional Ozone Plan and the Sacramento Metro portion of CARB's 2018 SIP Update:</P>
                <P>• The base year emissions inventory element in the 2017 Sacramento Regional Ozone Plan meets the requirements of CAA sections 172(c)(3) and 182(a)(1) and 40 CFR 51.1115 for the 2008 ozone NAAQS;</P>
                <P>• The RACM demonstration element in the 2017 Sacramento Regional Ozone Plan meets the requirements of CAA section 172(c)(1) and 40 CFR 51.1112(c) for the 2008 ozone NAAQS;</P>
                <P>• The attainment demonstration element for the 2008 ozone NAAQS in the 2017 Sacramento Regional Ozone Plan meets the requirements of CAA section 182(c)(2)(A) and 40 CFR 51.1108;</P>
                <P>• The ROP demonstration element in the 2017 Sacramento Regional Ozone Plan meets the requirements of CAA 182(b)(1) and 40 CFR 51.1110(a)(2) for the 2008 ozone NAAQS;</P>
                <P>• The RFP demonstration element in Section V—SIP Elements for the Sacramento Metropolitan Area of the 2018 SIP Update (as clarified) meets the requirements of CAA sections 172(c)(2), 182(b)(1), and 182(c)(2)(B), and 40 CFR 51.1110(a)(2)(ii) for the 2008 ozone NAAQS;</P>
                <P>• The VMT emissions offset demonstration element in the 2017 Sacramento Regional Ozone Plan meets the requirements of CAA section 182(d)(1)(A) and 40 CFR 51.1102 for the 2008 ozone NAAQS; and</P>
                <P>• The motor vehicle emissions budgets in Section V—SIP Elements for the Sacramento Metropolitan Area of the 2018 SIP Update for the RFP milestone year of 2023, and the attainment year of 2024 are consistent with the RFP and attainment demonstrations for the 2008 ozone NAAQS, and the budgets meet the other criteria in 40 CFR 93.118(e). In approving the budgets, we are also finding them adequate for use in transportation conformity determinations, consistent with 40 CFR 93.118(f)(2).</P>
                <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s50,12,12">
                    <TTITLE>Table 1—Transportation Conformity Motor Vehicle Emissions Budgets for the 2008 Ozone NAAQS in the Sacramento Metro Area </TTITLE>
                    <TDESC>[Summer planning inventory, tons per day]</TDESC>
                    <BOXHD>
                        <CHED H="1">Budget year</CHED>
                        <CHED H="1">VOC</CHED>
                        <CHED H="1">
                            NO
                            <E T="0732">X</E>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">2023</ENT>
                        <ENT>15</ENT>
                        <ENT>22</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">2024</ENT>
                        <ENT>15</ENT>
                        <ENT>21</ENT>
                    </ROW>
                    <TNOTE>Source:  85 FR 68509; Id. at 68530, Table 9; and 2018 SIP Update, Table V-4.</TNOTE>
                </GPOTABLE>
                <PRTPAGE P="58591"/>
                <P>We also find that the:</P>
                <P>• Emissions statement element of the 2017 Sacramento Regional Ozone Plan satisfies the requirements under CAA section 182(a)(3)(B) based on our prior approval of the Districts' emissions statement rules;</P>
                <P>• Enhanced vehicle inspection and maintenance program in the Sacramento Metro Area meets the requirements of CAA section 182(c)(3) and 40 CFR 51.1102 for the 2008 ozone NAAQS;</P>
                <P>• California SIP revision to opt out of the Federal Clean Fuels Fleet Program meets the requirements of CAA sections 182(c)(4)(A) and 246 and 40 CFR 51.1102 for the 2008 ozone NAAQS with respect to the Sacramento Metro Area; and</P>
                <P>• Enhanced monitoring in the Sacramento Metro Area meets the requirements of CAA section 182(c)(1) and 40 CFR 51.1102 for the 2008 ozone NAAQS.</P>
                <P>To conclude, we are deferring final action on the contingency measures element of the Sacramento Metro Area Ozone SIP as meeting the requirements of CAA sections 172(c)(9) and 182(c)(9).</P>
                <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 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 they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state plans 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);</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; and</P>
                <P>• Does not provide the EPA with the discretionary authority to address disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994).</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. Four Indian tribes have areas of Indian country located within the boundaries of the Sacramento Metro ozone nonattainment area. In those areas of Indian country, the rule does not have tribal implications and 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>
                    The Congressional Review Act, 5 U.S.C. 801 
                    <E T="03">et seq.,</E>
                     as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the 
                    <E T="04">Federal Register</E>
                    . A major rule cannot take effect until 60 days after it is published in the 
                    <E T="04">Federal Register</E>
                    . 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 December 21, 2021. 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, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.</P>
                </LSTSUB>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P>
                        42 U.S.C. 7401 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: October 9, 2021.</DATED>
                    <NAME>Deborah Jordan,</NAME>
                    <TITLE>Acting Regional Administrator, Region IX.</TITLE>
                </SIG>
                <P>Chapter I, title 40 of the Code of Federal Regulations 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>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart F—California</HD>
                </SUBPART>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>
                        2. Section 52.220 is amended by adding paragraphs (c)(514)(ii)(A)(
                        <E T="03">10</E>
                        ) and (c)(566) to read as follows:
                    </AMDPAR>
                    <SECTION>
                        <SECTNO>§ 52.220 </SECTNO>
                        <SUBJECT>Identification of plan—in part.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(514) * * *</P>
                        <P>(ii) * * *</P>
                        <P>(A) * * *</P>
                        <P>
                            (
                            <E T="03">10</E>
                            ) 2018 Updates to the California State Implementation Plan, adopted on October 25, 2018, chapter V (“SIP Elements for the Sacramento Metropolitan Area”), excluding section V.D (“Contingency Measures”); and pages A-15 through A-18 of Appendix A (“Nonattainment Area Inventories”).
                        </P>
                        <STARS/>
                        <P>(566) The following plan was submitted on December 18, 2017 by the Governor's designee.</P>
                        <P>(i) [Reserved]</P>
                        <P>
                            (ii) 
                            <E T="03">Additional materials.</E>
                             (A) Sacramento Metropolitan Area 2008 8-Hour Ozone National Ambient Air Quality Standard Planning Area.
                        </P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Sacramento Regional 2008 NAAQS 8-Hour Ozone Attainment and Reasonable Further Progress Plan, dated July 24, 2017, excluding the following portions: Subchapter 7.9, “Contingency Measures”; subchapter 10.5, “Proposed New Motor Vehicle Emissions Budgets”; and chapter 12 (regarding reasonable further progress).
                            <PRTPAGE P="58592"/>
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) [Reserved]
                        </P>
                        <P>(B) [Reserved]</P>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-22661 Filed 10-21-21; 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-2019-0272; FRL-8897-02-Region 9]</DEPDOC>
                <SUBJECT>Air Plan Approval; California; South Coast Air Quality Management District; Stationary Source Permits</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 approve a revision to the South Coast Air Quality Management District (SCAQMD or “the District”) portion of the California State Implementation Plan (SIP). We are finalizing approval of a revision governing issuance of permits for stationary sources, including review and permitting of major sources and major modifications under part D of title I of the Clean Air Act (CAA or “the Act”). Specifically, the revision pertains to SCAQMD Rule 1325 “Federal PM
                        <E T="52">2.5</E>
                         New Source Review Program.”
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective on November 22, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The EPA has established a docket for this action under Docket No. EPA-R09-OAR-2019-0272. 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 the disclosure of which 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 disabilities 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>
                        Laura Yannayon, EPA Region IX, 75 Hawthorne St., San Francisco, CA 94105. By phone: (415) 972-3534 or by email at 
                        <E T="03">yannayon.laura@epa.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <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. Proposed Action</FP>
                    <FP SOURCE="FP-2">II. Public Comments and EPA Responses</FP>
                    <FP SOURCE="FP-2">III. EPA Action</FP>
                    <FP SOURCE="FP-2">IV. Incorporation by Reference</FP>
                    <FP SOURCE="FP-2">V. Statutory and Executive Order Reviews</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Proposed Action</HD>
                <P>
                    On September 20, 2019,
                    <SU>1</SU>
                    <FTREF/>
                     the EPA proposed to approve the following rule into the California SIP. Table 1 lists the rule addressed by this final action with the dates that it was adopted by the local air agency and submitted to the EPA by the California Air Resources Board (CARB or “the State”).
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         84 FR 49492.
                    </P>
                </FTNT>
                <GPOTABLE COLS="04" OPTS="L2,i1" CDEF="s50,r100,12C,12C">
                    <TTITLE>Table 1—Submitted Rule</TTITLE>
                    <BOXHD>
                        <CHED H="1">Rule No.</CHED>
                        <CHED H="1">Rule Title</CHED>
                        <CHED H="1">Amended</CHED>
                        <CHED H="1">Submitted</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">1325</ENT>
                        <ENT>
                            Federal PM
                            <E T="0732">2.5</E>
                             New Source Review Program
                        </ENT>
                        <ENT>1/4/2019</ENT>
                        <ENT>4/24/19</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    The SIP previously contained a version of Rule 1325 “Federal PM
                    <E T="52">2.5</E>
                     New Source Review Program,” approved into the SIP on November 30, 2018.
                    <SU>2</SU>
                    <FTREF/>
                     The EPA's final approval of the rule identified above in Table 1 has the effect of entirely superseding our prior approval of the same rule in the current SIP-approved program.
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         83 FR 61551.
                    </P>
                </FTNT>
                <P>Our proposed action contains more information on the rule and our evaluation.</P>
                <HD SOURCE="HD1">II. Public Comments and EPA Responses</HD>
                <P>The EPA's proposed action provided a 30-day public comment period. During this period, we received one non-germane comment and one adverse comment. The full text of both comments is available in the docket for this rulemaking. Below, we summarize the adverse comment and our response.</P>
                <P>
                    <E T="03">Comment:</E>
                     The commenter stated that the definition of Volatile Organic Compounds (VOC) as referenced in Rule 1325 does not comport with the definition in 40 CFR 51.100. The definition of VOC in Rule 1325 points to the term as it is defined in SIP-approved SCAQMD Rule 102, which defines VOC as “any volatile organic compound of carbon, excluding methane, carbon monoxide, carbon dioxide, carbonic acid, metallic carbides or carbonates, ammonium carbonate, and exempt compounds.” The list of “exempt compounds” in Rule 102 has not been updated since 2004 and thus is out of compliance with the federal definition.
                </P>
                <P>
                    <E T="03">Response:</E>
                     Since the publication of our proposed action to approve Rule 1325, the SCAQMD amended Rule 102 on January 10, 2020 and the California Air Resources Board submitted the amended version of SCAQMD Rule 102 to the EPA for incorporation into the SIP on September 16, 2020. On July 9, 2021,
                    <SU>3</SU>
                    <FTREF/>
                     the EPA took final action to approve amended SCAQMD Rule 102 into the SIP based, in part, on our determination that the amended definition is consistent with the federal definition in 40 CFR 51.100. The EPA's approval of SCAQMD Rule 102 corrected the deficiency identified by the commenter. Accordingly, the EPA is finalizing our action on SCAQMD Rule 1325 as proposed.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         86 FR 36227.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">III. EPA Action</HD>
                <P>As explained above, the SCAQMD and the EPA have taken all steps necessary to address the deficiency identified by the commenter. We find that SCAQMD Rule 1325 fulfills all relevant CAA requirements. As authorized in section 110(k)(3) of the Act, the EPA is fully approving Rule 1325 into the SCAQMD portion of the California SIP. The January 4, 2019 version of Rule 1325 will replace the previously approved version of the rule in the SIP.</P>
                <HD SOURCE="HD1">IV. Incorporation by Reference</HD>
                <P>
                    In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the rule listed in Table 1 of this preamble. The EPA has made, and will continue to make, these materials available 
                    <PRTPAGE P="58593"/>
                    electronically through 
                    <E T="03">https://www.regulations.gov</E>
                     and in hard copy at the EPA Region IX Office (please contact the person identified in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section of this preamble for more information).
                </P>
                <HD SOURCE="HD1">V. Statutory and Executive 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>
                <P>Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the 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 CAA. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this 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);</P>
                <P>• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and</P>
                <P>• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).</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 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>
                    The Congressional Review Act, 5 U.S.C. 801 
                    <E T="03">et seq.,</E>
                     as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the 
                    <E T="04">Federal Register</E>
                    . A major rule cannot take effect until 60 days after it is published in the 
                    <E T="04">Federal Register</E>
                    . 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 December 21, 2021. 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, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur Oxides, Volatile organic compounds.</P>
                </LSTSUB>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P>
                        42 U.S.C. 7401 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: October 14, 2021.</DATED>
                    <NAME>Deborah Jordan,</NAME>
                    <TITLE>Acting Regional Administrator, Region IX.</TITLE>
                </SIG>
                <P>Chapter I, title 40 of the Code of Federal Regulations 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>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart F—California</HD>
                </SUBPART>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>
                        2. Section 52.220 is amended by adding paragraphs (c)(509)(i)(A)(
                        <E T="03">2</E>
                        ) and (c)(564) to read as follows:
                    </AMDPAR>
                    <SECTION>
                        <SECTNO>§ 52.220 </SECTNO>
                        <SUBJECT>Identification of plan—in part.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(509) * * *</P>
                        <P>(i) * * *</P>
                        <P>(A) * * *</P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Previously approved on November 30, 2018 in paragraph (c)(509)(A)(
                            <E T="03">1</E>
                            ) of this section and now deleted with replacement in paragraph (c)(564)(i)(A)(
                            <E T="03">1</E>
                            ), Rule 1325.
                        </P>
                        <STARS/>
                        <P>(564) New and amended regulations for the following APCDs were submitted on April 24, 2019 by the Governor's designee.</P>
                        <P>(i) Incorporation by Reference.</P>
                        <P>(A) South Coast Air Quality Management District.</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Rule 1325, “Federal PM
                            <E T="52">2.5</E>
                             New Source Review Program” amended on January 4, 2019.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) [Reserved]
                        </P>
                        <P>(B) [Reserved]</P>
                        <P>(ii) [Reserved]</P>
                    </SECTION>
                </REGTEXT>
                <SECTION>
                    <SECTNO>§ 52.248 </SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>3. Section 52.248 is amended by removing and reserving paragraph (f).</AMDPAR>
                    <STARS/>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-22884 Filed 10-21-21; 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-2021-0371; FRL-8746-02-R9]</DEPDOC>
                <SUBJECT>Air Plan Approval; California; San Diego Air Pollution Control District</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 approve revisions to the San Diego Air Pollution Control District (SDAPCD) portion of the California State Implementation Plan (SIP). These revisions concern emissions of volatile 
                        <PRTPAGE P="58594"/>
                        organic compounds (VOCs) from cold solvent cleaning and stripping operations, and from vapor degreasing operations. We are approving revisions to local rules that regulate these emission sources under the Clean Air Act (CAA or the Act).
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective on November 22, 2021.</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-2021-0371. 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 disabilities 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>
                        Robert Schwartz, EPA Region IX, 75 Hawthorne St., San Francisco, CA 94105. By phone: (415) 972-3286 or by email at 
                        <E T="03">schwartz.robert@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <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. Proposed Action</FP>
                    <FP SOURCE="FP-2">II. Public Comments and EPA Responses</FP>
                    <FP SOURCE="FP-2">III. EPA Action</FP>
                    <FP SOURCE="FP-2">IV. Incorporation by Reference</FP>
                    <FP SOURCE="FP-2">V. Statutory and Executive Order Reviews</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Proposed Action</HD>
                <P>On August 10, 2021 (86 FR 43615), the EPA proposed to approve the following rules into the California SIP.</P>
                <GPOTABLE COLS="5" OPTS="L2,tp0,i1" CDEF="s50,12,r100,12,12">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Local agency</CHED>
                        <CHED H="1">Rule No.</CHED>
                        <CHED H="1">Rule title</CHED>
                        <CHED H="1">Revised and adopted</CHED>
                        <CHED H="1">Submitted</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">SDAPCD</ENT>
                        <ENT>67.6.1</ENT>
                        <ENT>Cold Solvent Cleaning and Stripping Operations</ENT>
                        <ENT>02/10/2021</ENT>
                        <ENT>04/20/2021</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SDAPCD</ENT>
                        <ENT>67.6.2</ENT>
                        <ENT>Vapor Degreasing Operations</ENT>
                        <ENT>02/10/2021</ENT>
                        <ENT>04/20/2021</ENT>
                    </ROW>
                </GPOTABLE>
                <P>We proposed to approve these rules because we determined that they comply with the relevant CAA requirements. Our proposed action contains more information on the rules and our evaluation.</P>
                <HD SOURCE="HD1">II. Public Comments and EPA Responses</HD>
                <P>The EPA's proposed action provided a 30-day public comment period. During this period, we received one non-germane comment.</P>
                <HD SOURCE="HD1">III. EPA Action</HD>
                <P>
                    No comments were submitted that change our assessment of the rules as described in our proposed action. The revisions to Rule 67.6.1 cure the deficiency identified in our partial disapproval of SDAPCD's 2016 reasonably available control technology (RACT) SIP 
                    <SU>1</SU>
                    <FTREF/>
                     with respect to the requirement to establish RACT-level controls for sources covered by the “Control Techniques Guidelines for Industrial Cleaning Solvents” 
                    <SU>2</SU>
                    <FTREF/>
                     (“CTG”), and addresses our obligation to promulgate a Federal Implementation Plan for this CTG source category associated with our partial disapproval of the District's 2016 RACT SIP.
                    <SU>3</SU>
                    <FTREF/>
                     Additionally, the District revised Rule 67.6.2 to increase the stringency to qualify for an exemption to the rule. Therefore, as authorized in section 110(k)(3) of the Act, the EPA is fully approving these rules into the California SIP. The February 10, 2021 versions of Rule 67.6.1 and Rule 67.6.2 will replace the previously approved versions of these rules in the SIP.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         85 FR 77996 (December 3, 2020) and 85 FR 48127 (August 10, 2020).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         “Control Techniques Guidelines for Industrial Cleaning Solvents,” EPA-453/R-06-001, September 2006.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Sanctions and FIP clocks still apply as they relate to deficiencies in other CTG source categories identified elsewhere in our partial disapproval of the District's 2016 RACT SIP (85 FR 77996).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">IV. Incorporation by Reference</HD>
                <P>
                    In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the SDAPCD rules described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents available through 
                    <E T="03">www.regulations.gov</E>
                     and at the EPA Region IX Office (please contact the person identified in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section of this preamble for more information).
                </P>
                <HD SOURCE="HD1">V. Statutory and Executive 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 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);</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; and</P>
                <P>
                    • Does not provide the EPA with the discretionary authority to address, as 
                    <PRTPAGE P="58595"/>
                    appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
                </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 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>
                    The Congressional Review Act, 5 U.S.C. 801 
                    <E T="03">et seq.,</E>
                     as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the 
                    <E T="04">Federal Register</E>
                    . A major rule cannot take effect until 60 days after it is published in the 
                    <E T="04">Federal Register</E>
                    . 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 December 21, 2021. 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, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.</P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated: October 13, 2021.</DATED>
                    <NAME>Deborah Jordan,</NAME>
                    <TITLE>Acting Regional Administrator, Region IX.</TITLE>
                </SIG>
                <P>For the reasons stated in the preamble, the Environmental Protection Agency amends Part 52, chapter I, title 40 of the Code of Federal Regulations 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>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart F—California</HD>
                </SUBPART>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>
                        2. Section 52.220 is amended by adding paragraphs (c)(354)(i)(F)(
                        <E T="03">5</E>
                        ), (c)(354)(i)(F)(
                        <E T="03">6</E>
                        ) and (c)(565) to read as follows:
                    </AMDPAR>
                    <SECTION>
                        <SECTNO>§ 52.220 </SECTNO>
                        <SUBJECT>Identification of plan-in part.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(354) * * *</P>
                        <P>(i) * * *</P>
                        <P>(F) * * *</P>
                        <P>
                            (
                            <E T="03">5</E>
                            ) Previously approved on October 13, 2009 in paragraph (c)(354)(i)(F)(1) of this section and now deleted with replacement in (c)(565)(i)(A)(1), Rule 67.6.1, “Cold Solvent Cleaning and Stripping Operations,” adopted May 23, 2007.
                        </P>
                        <P>
                            (
                            <E T="03">6</E>
                            ) Previously approved on October 13, 2009 in paragraph (c)(354)(i)(F)(2) of this section and now deleted with replacement in (c)(565)(i)(A)(2), Rule 67.6.2, “Vapor Degreasing Operations,” adopted May 23, 2007.
                        </P>
                        <STARS/>
                        <P>(565) Amended regulations for the following APCDs were submitted on April 20, 2021 by the Governor's designee as an attachment to a letter dated April 16, 2021.</P>
                        <P>(i) Incorporation by reference.</P>
                        <P>(A) San Diego Air Pollution Control District.</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Rule 67.6.1, “Cold Solvent Cleaning and Stripping Operations,” adopted on February 10, 2021.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Rule 67.6.2, “Vapor Degreasing Operations,” adopted on February 10, 2021.
                        </P>
                        <P>(B) [Reserved]</P>
                        <P>(ii) [Reserved]</P>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-22885 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <CFR>50 CFR Part 648</CFR>
                <DEPDOC>[Docket No. 201209-0332]</DEPDOC>
                <RIN>RTID 0648-XB525</RIN>
                <SUBJECT>Fisheries of the Northeastern United States; Atlantic Bluefish Fishery; Quota Transfers from NJ to RI and MD to NC</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>Notification; quota transfers.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>NMFS announces that the states of New Jersey and Maryland are transferring a portion of their 2021 commercial bluefish quota to the States of Rhode Island and North Carolina, respectively. These quota adjustments are necessary to comply with the Atlantic Bluefish Fishery Management Plan quota transfer provisions. This announcement informs the public of the revised commercial bluefish quotas for New Jersey, Rhode Island, Maryland, and North Carolina.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective October 21, 2021, through December 31, 2021.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Laura Hansen, Fishery Management Specialist, (978) 281-9225.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Regulations governing the Atlantic bluefish fishery are found in 50 CFR 648.160 through 648.167. These regulations require annual specification of a commercial quota that is apportioned among the coastal states from Maine through Florida. The process to set the annual commercial quota and the percent allocated to each state is described in § 648.162, and the final 2021 allocations were published on December 16, 2020 (85 FR 81421).</P>
                <P>
                    The final rule implementing Amendment 1 to the Bluefish Fishery Management Plan (FMP) published in the 
                    <E T="04">Federal Register</E>
                     on July 26, 2000 (65 FR 45844), and provided a mechanism for transferring bluefish quota from one state to another. Two or more states, under mutual agreement and with the concurrence of the NMFS Greater Atlantic Regional Administrator, can request approval to transfer or combine bluefish commercial quota under § 648.162(e)(1)(i) through (iii). The Regional Administrator must approve any such transfer based on the criteria in § 648.162(e). In evaluating requests to transfer a quota or combine 
                    <PRTPAGE P="58596"/>
                    quotas, the Regional Administrator shall consider whether: The transfer or combinations would preclude the overall annual quota from being fully harvested; the transfer addresses an unforeseen variation or contingency in the fishery; and the transfer is consistent with the objectives of the FMP and the Magnuson-Stevens Act.
                </P>
                <P>New Jersey is transferring 30,000 lb (13,608 kg) to Rhode Island, and Maryland is transferring 30,000 lb (13,608 kg) to North Carolina through mutual agreement of the states. These transfers were requested to ensure that Rhode Island and North Carolina would not exceed their 2021 state quota. The revised bluefish quotas for 2021 are: New Jersey, 290,082 lb (131,579 kg); Rhode Island, 253,434 lb (114,955 kg); Maryland 53,084 lb (24,078 kg); and, North Carolina, 957,377 lb (434,259 kg).</P>
                <HD SOURCE="HD1">Classification</HD>
                <P>NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR 648.162(e)(1)(i) through (iii), which was issued pursuant to section 304(b), and is exempted from review under Executive Order 12866.</P>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P>
                        16 U.S.C. 1801 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>Jennifer M. Wallace,</NAME>
                    <TITLE>Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23054 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <CFR>50 CFR Part 679</CFR>
                <DEPDOC>[Docket No. 210201-0018; RTID 0648-XB183]</DEPDOC>
                <SUBJECT>Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Ocean Perch in the Western Regulatory Area of the Gulf of Alaska</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Temporary rule; closure.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>NMFS is prohibiting directed fishing for Pacific ocean perch in the Western Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2021 total allowable catch of Pacific ocean perch in the Western Regulatory Area of the GOA.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective 1,200 hours, Alaska local time (A.l.t.), October 19, 2021, through 2,400 hours, A.l.t., December 31, 2021.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Steve Whitney, 907-586-7228.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.</P>
                <P>The 2021 total allowable catch (TAC) of Pacific ocean perch in the Western Regulatory Area of the GOA is 1,643 metric tons (mt) as established by the final 2021 and 2022 harvest specifications for groundfish of the GOA (86 FR 10184, February 19, 2021).</P>
                <P>In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2021 TAC of Pacific ocean perch in the Western Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 1,535 mt, and is setting aside the remaining 108 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific ocean perch in the Western Regulatory Area of the GOA.</P>
                <P>While this closure is in effect the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.</P>
                <HD SOURCE="HD1">Classification</HD>
                <P>NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR part 679, which was issued pursuant to section 304(b), and is exempt from review under Executive Order 12866.</P>
                <P>Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest, as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of directed fishing of Pacific ocean perch in the Western Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of October 18, 2021.</P>
                <P>The Assistant Administrator for Fisheries, NOAA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.</P>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>
                        16 U.S.C. 1801 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>Jennifer M. Wallace,</NAME>
                    <TITLE>Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23102 Filed 10-19-21; 4:15 pm]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </RULE>
    </RULES>
    <VOL>86</VOL>
    <NO>202</NO>
    <DATE>Friday, October 22, 2021</DATE>
    <UNITNAME>Proposed Rules</UNITNAME>
    <PRORULES>
        <PRORULE>
            <PREAMB>
                <PRTPAGE P="58597"/>
                <AGENCY TYPE="F">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 39</CFR>
                <DEPDOC>[Docket No. FAA-2021-0883; Project Identifier AD-2021-00307-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 supersede Airworthiness Directive (AD) 2020-16-01, which applies to all Airbus SAS Model A318, A319, A320, and A321 series airplanes. AD 2020-16-01 requires repetitive cleaning and greasing of affected cargo door seals (both original equipment manufacturer (OEM) and parts manufacturer approval (PMA) parts). Since the FAA issued AD 2020-16-01, the FAA determined that improved cargo door seals must be installed to address the unsafe condition, and that certain flight operations must be limited until the improved cargo door seals are installed. In addition, the FAA has issued a new AD to address the OEM parts. This proposed AD would limit the applicability to airplanes that have certain PMA parts installed. This proposed AD would retain certain actions required by AD 2020-16-01 and require replacing certain forward and aft cargo compartment door seals with new seals and installing a placard on the cargo compartment doors; and for certain airplanes, implementing an operational limitation for certain routes. 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 December 6, 2021.</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">https://www.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>
                        For Airbus service information identified in this NPRM, contact Airbus SAS, Airworthiness Office—EIAS, Rond-Point Emile Dewoitine No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email 
                        <E T="03">account.airworth-eas@airbus.com;</E>
                         internet 
                        <E T="03">https://www.airbus.com.</E>
                         For EASA material identified 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>
                         internet 
                        <E T="03">www.easa.europa.eu.</E>
                         You may find this material on the EASA website at 
                        <E T="03">https://ad.easa.europa.eu.</E>
                         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>
                <HD SOURCE="HD1">Examining the AD Docket</HD>
                <P>
                    You may examine the AD docket at 
                    <E T="03">https://www.regulations.gov</E>
                     by searching for and locating Docket No. FAA-2021-0883; 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, any comments received, and other information. The street address for Docket Operations is listed above.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        John Marshall, Aerospace Engineer, Airframe Section, FAA, Atlanta ACO Branch, 1701 Columbia Avenue, College Park, GA 30337; phone: 404-474-5524; fax: 404-474-5606; email: 
                        <E T="03">John.R.Marshall@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>
                    The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under 
                    <E T="02">ADDRESSES</E>
                    . Include “Docket No. FAA-2021-0883; Project Identifier AD-2021-00307-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">https://www.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 John Marshall, Aerospace Engineer, Airframe Section, FAA, Atlanta ACO Branch, 1701 Columbia Avenue, College Park, GA 30337; phone: 404-474-5524; fax: 404-474-5606; email: 
                    <E T="03">John.R.Marshall@faa.gov.</E>
                     Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    The FAA issued AD 2020-16-01, Amendment 39-21185 (85 FR 47013, August 4, 2020) (AD 2020-16-01), for all Airbus SAS Model A318, A319, A320, and A321 series airplanes. AD 
                    <PRTPAGE P="58598"/>
                    2020-16-01 was prompted by reports of low halon concentration in the forward and aft cargo compartments due to air leakage through cargo door seals. AD 2020-16-01 requires repetitive cleaning and greasing of forward and aft cargo door seals having part number (P/N) D5237106020000, D5237106020200, D5237106020400, D5237300120000, or D5237300120200 (OEM parts); bulk cargo door seals having P/N D5237200220000 or D5237200220200 (OEM parts); and forward and aft cargo door seals P/N D5237106020400S, approved under PMA PQ1715CE (PMA part). The agency issued AD 2020-16-01 to address low halon concentration, which, if not addressed, could affect the fire extinguishing system efficiency in the cargo compartments and possibly result in failure of the system to contain a cargo compartment fire.
                </P>
                <P>The FAA has also issued AD 2021-18-04, Amendment 39-21705 (86 FR 51265, September 15, 2021) (AD 2021-18-04), which applies to all Airbus SAS Model A318, A319, A320, and A321 series airplanes and addresses the OEM parts. That AD requires repetitive cleaning and greasing of affected OEM cargo door seals; replacing certain forward, aft, and bulk cargo compartment door seals with new seals and installing a placard on the cargo compartment doors; and for certain airplanes, implementing an operational limitation for certain routes. Paragraph (h)(2) of AD 2021-18-04 explains conditions under which operators will no longer need to show compliance with certain requirements of AD 2020-16-01 for affected OEM parts. AD 2021-18-04 also states that the FAA is considering additional rulemaking to require replacement of PMA cargo door seals approved for the type design forward and aft cargo compartment door seal P/N D5237106020400, including but not limited to PMA P/N D5237106020400S.</P>
                <P>The FAA has determined additional rulemaking is necessary to require replacement of PMA P/N D5237106020400S with improved cargo door seals and to limit certain flight operations until the improved cargo door seals are installed. This NPRM addresses the identified unsafe condition for PMA forward and aft cargo door seals approved for the type design forward and aft cargo compartment door seal P/N D5237106020400, including but not limited to PMA P/N D5237106020400S.</P>
                <HD SOURCE="HD1">FAA's Determination</HD>
                <P>The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.</P>
                <HD SOURCE="HD1">Related Service Information Under 1 CFR Part 51</HD>
                <P>The FAA reviewed Airbus Service Bulletin A320-52-1195, Revision 01, dated December 15, 2020, and Airbus Service Bulletin A320-52-1196, dated October 12, 2020. This service information specifies procedures for replacing the forward and aft cargo compartment door seals with new seals, among other actions, and installing a placard on the cargo compartment doors. These documents are distinct since they apply to different airplane models.</P>
                <P>This proposed AD also requires European Union Aviation Safety Agency (EASA) AD 2021-0049, dated February 18, 2021, which the Director of the Federal Register approved for incorporation by reference as of October 20, 2021 (86 FR 51265, September 15, 2021).</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">Proposed AD Requirements in This NPRM</HD>
                <P>This proposed AD would continue to require repetitive cleaning and greasing, and would require replacing certain PMA forward and aft cargo compartment door seals with new seals and installing a placard on the cargo compartment doors; and for certain airplanes, implementing an operational limitation for certain routes.</P>
                <HD SOURCE="HD1">Explanation of Service Information</HD>
                <P>Although the service information described previously specifies replacing OEM parts, PMA parts are similar in design to the OEM parts; therefore the service information may be used for airplanes on which the PMA parts are installed. However, if the service information cannot be used, operators may request an alternative method of compliance in accordance with the procedures specified in paragraph (m) of this AD.</P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this AD, if adopted as proposed, would affect 1,768 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:</P>
                <GPOTABLE COLS="5" OPTS="L2,nj,i1" CDEF="s75,r50,xs60,r40,r54">
                    <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">Cleaning and greasing (retained actions from AD 2020-16-01)</ENT>
                        <ENT>1 work-hour × $85 per hour = $85, per cleaning/greasing cycle</ENT>
                        <ENT>$0</ENT>
                        <ENT>$85, per cleaning/greasing cycle</ENT>
                        <ENT>$150,280, per cleaning/greasing cycle.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Cargo door seal replacement and placard installation (new proposed action)</ENT>
                        <ENT>8 work-hours × $85 per hour = $680</ENT>
                        <ENT>Up to $5,680</ENT>
                        <ENT>Up to $6,360</ENT>
                        <ENT>Up to $11,244,480.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            Operational limitation implementation (
                            <E T="03">e.g.,</E>
                             revising the airplane flight manual) (new proposed action)
                        </ENT>
                        <ENT>1 work-hour × $85 per hour = $85</ENT>
                        <ENT>$0</ENT>
                        <ENT>$85</ENT>
                        <ENT>Up to $150,280 (Group 3 airplanes only).</ENT>
                    </ROW>
                </GPOTABLE>
                <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.
                    <PRTPAGE P="58599"/>
                </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:</AMDPAR>
                <AMDPAR>a. Removing Airworthiness Directive (AD) 2020-16-01, Amendment 39-21185 (85 FR 47013, August 4, 2020), and</AMDPAR>
                <AMDPAR>b. Adding the following new AD:</AMDPAR>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        <E T="04">Airbus SAS:</E>
                         Docket No. FAA-2021-0883; Project Identifier AD-2021-00307-T.
                    </FP>
                    <HD SOURCE="HD1">(a) Comments Due Date</HD>
                    <P>The FAA must receive comments on this airworthiness directive (AD) by December 6, 2021.</P>
                    <HD SOURCE="HD1">(b) Affected ADs</HD>
                    <P>This AD replaces AD 2020-16-01, Amendment 39-21185 (85 FR 47013, August 4, 2020) (AD 2020-16-01).</P>
                    <HD SOURCE="HD1">(c) Applicability</HD>
                    <P>This AD applies to the Airbus SAS airplanes identified in paragraphs (c)(1) through (4) of this AD, certificated in any category, equipped with any parts manufacturer approval (PMA) part approved for the type design forward and aft cargo compartment door seal part number (P/N) D5237106020400, including but not limited to PMA P/N D5237106020400S.</P>
                    <P>(1) Model A318-111, -112, -121, and -122 airplanes.</P>
                    <P>(2) Model A319-111, -112, -113, -114, -115, -131, -132, -133, -151N, -153N, and -171N airplanes.</P>
                    <P>(3) Model A320-211, -212, -214, -215, -216, -231, -232, -233, -251N, -252N, -253N, -271N, -272N, and -273N airplanes.</P>
                    <P>(4) Model A321-111, -112, -131, -211, -212, -213, -231, -232, -251N, -251NX, -252N, -252NX, -253N, -253NX, -271N, -271NX, -272N, and -272NX airplanes.</P>
                    <HD SOURCE="HD1">(d) Subject</HD>
                    <P>Air Transport Association (ATA) of America Code 26, Fire protection; 52, Doors.</P>
                    <HD SOURCE="HD1">(e) Unsafe Condition</HD>
                    <P>This AD was prompted by reports of low halon concentration in the forward and aft cargo compartments due to air leakage through cargo compartment door seals, and the certification of improved cargo compartment door seals. The FAA is issuing this AD to address low halon concentration. This condition, if not corrected, could affect the fire extinguishing system efficiency in the cargo compartments, possibly resulting in failure of the system to contain a cargo compartment fire.</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) Definition</HD>
                    <P>For the purposes of this AD, a “PMA part” is defined as any PMA part approved for the type design forward and aft cargo compartment door seal P/N D5237106020400, including but not limited to PMA P/N D5237106020400S.</P>
                    <HD SOURCE="HD1">(h) Retained Cleaning and Greasing, With Revised Compliance Language</HD>
                    <P>This paragraph restates the requirements of paragraph (g) of AD 2020-16-01, with revised compliance language. Within 6 months after the airplane date of manufacture, or 3 months after August 19, 2020 (the effective date of AD 2020-16-01), whichever occurs later, and, thereafter, at intervals not exceeding 6 months, clean and grease each PMA part, in accordance with the instructions specified in paragraph (1) or (2) of European Union Aviation Safety Agency (EASA) AD 2021-0049, dated February 18, 2021. Accomplishing the actions required by paragraph (i) of this AD on an airplane terminates the actions required by this paragraph for that airplane only, and for the specific cargo door locations with PMA parts only.</P>
                    <HD SOURCE="HD1">(i) Modification</HD>
                    <P>Within 96 months after the effective date of this AD, replace the seals of the PMA part with new seals and install a placard on the cargo compartment doors, in accordance with the method specified in paragraph (i)(1) or (2) of this AD. Accomplishing the actions required by this paragraph terminates the actions required by paragraph (h) of this AD for that airplane only, and for the specific cargo door locations where PMA parts were replaced only.</P>
                    <P>(1) Do the actions in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-52-1195, Revision 01, dated December 15, 2020, or Airbus Service Bulletin A320-52-1196, dated October 12, 2020, as applicable, except where the procedures refer to P/N D5237106020400, those procedures must be used for the PMA part.</P>
                    <P>(2) Do the actions in accordance with the procedures specified in paragraph (m)(1) of this AD.</P>
                    <HD SOURCE="HD1">(j) Operational Limitation</HD>
                    <P>For Model A319 airplanes on which Airbus mod 26402, mod 34881 or mod 34882 has been embodied in production, or Airbus Service Bulletin A320-26-1066 or Airbus Service Bulletin A320-26-1076 has been embodied in service: As of 9 months after the effective date of this AD, or upon the accumulation of 1,600 flight hours by the airplane after the effective date of this AD, whichever occurs later, do not operate an airplane over a route having a point with a diversion time of more than 60 minutes, unless that airplane has been modified as required by paragraph (i) of this AD. Amending the existing aircraft flight manual (AFM) of the airplane by inserting a copy of this AD, and restricting operations to routes having diversion times of 60 minutes or less, is an acceptable method to comply with the operational limitation requirement for that airplane. After modification of an airplane as required by this paragraph (i) of this AD, this limitation is no longer required and can be removed from the AFM of that airplane.</P>
                    <HD SOURCE="HD1">(k) Credit for Previous Actions</HD>
                    <P>(1) This paragraph provides credit for the actions specified in paragraph (h) of this AD, if those actions were performed before the effective date of this AD using Airbus Technical Adaption 80774334/003/2020, Issue 1, dated April 1, 2020.</P>
                    <P>(2) This paragraph provides credit for the actions specified in paragraph (h) of this AD, if those actions were performed before the effective date of this AD using EASA AD 2020-0133, dated June 10, 2020.</P>
                    <P>(3) This paragraph provides credit for the actions specified in paragraph (i) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A320-52-1195, dated October 12, 2020.</P>
                    <HD SOURCE="HD1">(l) Parts Installation Prohibition</HD>
                    <P>Do not install a PMA part, or a door equipped with a PMA part, on any airplane, as required by paragraph (l)(1) or (2) of this AD, as applicable.</P>
                    <P>(1) For airplanes with a PMA part installed as of the effective date of this AD: After modification of the airplane as required by paragraph (i) of this AD.</P>
                    <P>(2) For airplanes that do not have a PMA part installed as of the effective date of this AD: As of the effective date of this AD.</P>
                    <HD SOURCE="HD1">(m) Alternative Methods of Compliance (AMOCs)</HD>
                    <P>
                        (1) The Manager, Atlanta 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 
                        <PRTPAGE P="58600"/>
                        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 Related Information.
                    </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) 
                        <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, Atlanta ACO Branch, FAA.
                    </P>
                    <P>
                        (4) 
                        <E T="03">Required for compliance (RC):</E>
                         Except as specified by paragraph (m)(3) 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">(n) Related Information</HD>
                    <P>
                        (1) For more information about this AD, contact John Marshall, Aerospace Engineer, Airframe Section, FAA, Atlanta ACO Branch, 1701 Columbia Avenue, College Park, GA 30337; phone: 404-474-5524; fax: 404-474-5606; email: 
                        <E T="03">John.R.Marshall@faa.gov.</E>
                    </P>
                    <P>
                        (2) For Airbus service information identified in this AD, contact Airbus SAS, Airworthiness Office—EIAS, Rond-Point Emile Dewoitine No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email 
                        <E T="03">account.airworth-eas@airbus.com;</E>
                         internet 
                        <E T="03">https://www.airbus.com.</E>
                         For EASA material identified in this AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email 
                        <E T="03">ADs@easa.europa.eu;</E>
                         internet 
                        <E T="03">www.easa.europa.eu.</E>
                         You may find this material on the EASA website at 
                        <E T="03">https://ad.easa.europa.eu.</E>
                         You may view this referenced 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>
                </EXTRACT>
                <SIG>
                    <DATED>Issued on October 14, 2021.</DATED>
                    <NAME>Lance T. Gant,</NAME>
                    <TITLE>Director, Compliance &amp; Airworthiness Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-22785 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 39</CFR>
                <DEPDOC>[Docket No. FAA-2021-0873; Project Identifier MCAI-2021-00336-R]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; Airbus Helicopters</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking (NPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The FAA proposes to supersede Airworthiness Directive (AD) 2018-11-01, which applies to certain Airbus Helicopters Model AS332L2 and EC225LP helicopters. AD 2018-11-01 requires installing a cut-out for the left-hand (LH) and right-hand (RH) rail support junction profiles and repetitively inspecting splices, frame 5295, and related equipment for a crack. Since the FAA issued AD 2018-11-01, the manufacturer has developed a modification for in-service helicopters for replacing aluminum splices with steel splices on frame 5295. This proposed AD would retain the requirements of AD 2018-11-01 and require a modification for replacing aluminum splices with steel splices on frame 5295 if cracking is found. This proposed AD would also provide terminating action for the repetitive inspections. 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 December 6, 2021.</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">https://www.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>
                        For service information identified in this NPRM, contact Airbus Helicopters, 2701 North Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at 
                        <E T="03">https://www.airbus.com/helicopters/services/technical-support.html.</E>
                         You may view this service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110.
                    </P>
                </ADD>
                <HD SOURCE="HD1">Examining the AD Docket</HD>
                <P>
                    You may examine the AD docket at 
                    <E T="03">https://www.regulations.gov</E>
                     by searching for and locating Docket No. FAA-2021-0873; 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 European Union Aviation Safety Agency (EASA) AD, any comments received, and other information. The street address for Docket Operations is listed above.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Andrea Jimenez, Aerospace Engineer, COS Program Management Section, Operational Safety Branch, Compliance &amp; Airworthiness Division, FAA, 1600 Stewart Ave., Suite 410, Westbury, NY 11590; telephone (516) 228-7330; email 
                        <E T="03">andrea.jimenez@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>
                    The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under 
                    <E T="02">ADDRESSES</E>
                    . Include “Docket No. FAA-2021-0873; Project Identifier MCAI-2021-00336-R” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend 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">https://www.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 
                    <PRTPAGE P="58601"/>
                    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 Andrea Jimenez, Aerospace Engineer, COS Program Management Section, Operational Safety Branch, Compliance &amp; Airworthiness Division, FAA, 1600 Stewart Ave., Suite 410, Westbury, NY 11590; telephone (516) 228-7330; email 
                    <E T="03">andrea.jimenez@faa.gov.</E>
                     Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>The FAA issued AD 2018-11-01, Amendment 39-19289 (83 FR 23778, May 23, 2018), (AD 2018-11-01), for Airbus Helicopters Model AS332L2 and EC225LP helicopters with an extended aluminum splice installed on frame 5295, except helicopters with steel splice kit part number 332A08-2649-3072 installed. AD 2018-11-01 requires installing a cut-out for the LH and RH rail support junction profiles and repetitively inspecting splices, frame 5295, and related equipment for a crack. AD 2018-11-01 was prompted by reports of cracks on frame 5295 and on splices installed to prevent those cracks. The FAA issued AD 2018-11-01 to address a crack in frame 5295, which if not detected and corrected, could lead to loss of structural integrity of the helicopter frame and subsequent loss of control of the helicopter.</P>
                <HD SOURCE="HD1">Actions Since AD 2018-11-01 Was Issued</HD>
                <P>Since the FAA issued AD 2018-11-01, EASA issued AD 2021-0075, dated March 16, 2021 (EASA AD 2021-0075), which supersedes EASA Emergency AD 2014-0098-E, dated April 25, 2014 (EASA Emergency AD 2014-0098-E). EASA advises that since EASA Emergency AD 2014-0098-E was issued, Airbus Helicopters developed MOD 0728463, available for helicopters in service through the applicable modification service bulletin, providing instructions to replace aluminum splices with steel splices on frame 5295. Airbus Helicopters also issued the applicable inspection alert service bulletins, as defined in EASA AD 2021-0075. Accordingly, EASA AD 2021-0075 retains the requirements of EASA Emergency AD 2014-0098-E, which is superseded, and requires a modification, replacing aluminum splices with steel splices on helicopters on which any cracked aluminum splice has been detected. EASA AD 2021-0075 also advises that the modification is terminating action for the repetitive inspections.</P>
                <HD SOURCE="HD1">FAA's Determination</HD>
                <P>These helicopters have been approved by EASA and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the European Union, EASA has notified the FAA about the unsafe condition described in its AD. The FAA is proposing this AD after evaluating all known relevant information and determining that the unsafe condition described previously is likely to exist or develop on other helicopters of the same type designs.</P>
                <HD SOURCE="HD1">Related Service Information Under 1 CFR Part 51</HD>
                <P>The FAA reviewed the following Airbus Helicopters service information.</P>
                <P>• Alert Service Bulletins Nos. AS332-05.00.97, Revision 1; and EC225-05A038, Revision 1; both dated February 9, 2021; which specify procedures for, among other actions, installing a cut-out for the LH and RH rail support junction profiles and inspecting splices, frame 5295, and related equipment for a crack. These documents are distinct since they apply to different helicopter models.</P>
                <P>• Service Bulletins Nos. AS332-53.01.97, Revision 0; and EC225-53-061, Revision 0; both dated February 9, 2021; which specify procedures for modifying the helicopter by replacing the aluminum LH and RH splices with steel splices under the plates and the brackets of the main gear box (MGB) bars. The modification includes taking reference readings of the brackets of the MGB bars, removing the MGB brackets and plates, removing the aluminum splices and inspecting the joggling areas for scratches or other damage, inspecting frame 5295 for cracking (including a dye penetrant inspection if the inspection results are not conclusive), identifying the current measurements (values) of the rivet and attachment plate holes for installation of the steel splice (including determining the values of the rivet holes and attachment plate holes on frame 5295 with a calibrated pad and determining the elongations of the holes and the lengths of the straps), modifying the door hinge rail brackets on the LH and RH sides, and installing the steel splices. These documents are distinct since they apply to different helicopter models.</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 the 
                    <E T="02">ADDRESSES</E>
                     section.
                </P>
                <HD SOURCE="HD1">Other Related Service Information</HD>
                <P>The FAA reviewed Eurocopter Helicopters (now Airbus Helicopters) Service Bulletin No. 53-003, Revision 4, for Model EC225LP helicopters and Service Bulletin No. 53.01.52, Revision 5, for Model AS332L2 helicopters, both dated July 23, 2010. The service bulletins specify procedures to reinforce frame 5295 by installing a new titanium plate underneath the fitting and a new widened aluminum splice below the upper corner of the door.</P>
                <P>The FAA also reviewed Airbus Helicopters Service Bulletin No. 05-019, Revision 4, dated September 22, 2014, for Model EC225 LP helicopters. This service information specifies procedures for cutting out the junction profiles.</P>
                <P>The FAA also reviewed Airbus Helicopters Alert Service Bulletins Nos. AS332-05.00.97, Revision 0; and EC225-05A038, Revision 0; both dated April 15, 2014; which specify procedures for, among other actions, installing a cut-out for the LH and RH rail support junction profiles and inspecting splices, frame 5295, and related equipment for a crack.</P>
                <HD SOURCE="HD1">Proposed AD Requirements in This NPRM</HD>
                <P>This proposed AD would retain all requirements of AD 2018-11-01 and require a modification for replacing aluminum splices with steel splices on frame 5295. This proposed AD would also provide terminating action for the repetitive inspections required by AD 2018-11-01. This proposed AD would also require accomplishing the actions specified in the service information already described, except as discussed under “Differences Between this AD and the EASA AD.”</P>
                <HD SOURCE="HD1">Redesignation of AD 2018-11-01 Paragraph Identifier</HD>
                <P>Since AD 2018-11-01 was issued, the AD format has been revised, and certain paragraphs have been rearranged. As a result, the corresponding paragraph</P>
                <PRTPAGE P="58602"/>
                <FP>identifiers have been redesignated in this proposed AD, as listed in the following table:</FP>
                <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s50,r50">
                    <TTITLE>Revised Paragraph Identifier</TTITLE>
                    <BOXHD>
                        <CHED H="1">Requirement in AD 2018-11-01</CHED>
                        <CHED H="1">
                            Corresponding
                            <LI>requirement in this</LI>
                            <LI>proposed AD</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">paragraph (e)</ENT>
                        <ENT>paragraph (g).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">paragraph (f)</ENT>
                        <ENT>paragraph (j)(1).</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">Differences Between This Proposed AD and the EASA AD 2021-0075</HD>
                <P>EASA AD 2021-0075 requires contacting Airbus Helicopters for approved repair instructions if any crack is found during an inspection. This proposed AD would not require that action.</P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this AD, if adopted as proposed, would affect 38 helicopters of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:</P>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,r50,10,xs72,xs72">
                    <TTITLE>Estimated Costs for Required Actions</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>
                        <CHED H="1">
                            Cost on U.S.
                            <LI>operators</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Retained installation of cut-outs on frame 5295 from AD 2018-11-01</ENT>
                        <ENT>40 work-hours × $85 per hour = $3,400</ENT>
                        <ENT>$5,000</ENT>
                        <ENT>$8,400</ENT>
                        <ENT>$319,200.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Retained inspection of frame 5295 from AD 2018-11-01</ENT>
                        <ENT>2 work-hours × $85 per hour = $170, per inspection cycle</ENT>
                        <ENT>0</ENT>
                        <ENT>$170, per inspection cycle</ENT>
                        <ENT>$6,460, per inspection cycle.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The FAA estimates the following costs to do any necessary repairs that would be required based on the results of the proposed inspection. The agency has no way of determining the number of aircraft that might need these repairs:</P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,r50,12,12">
                    <TTITLE>Estimated Costs of On-Condition Actions</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">Repair</ENT>
                        <ENT>40 work-hours × $85 per hour = $3,400</ENT>
                        <ENT>$5,000</ENT>
                        <ENT>$8,400</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">New proposed modification (replacement of aluminum splices with steel splices)</ENT>
                        <ENT>830 work-hours × $85 per hour = $70,550</ENT>
                        <ENT>35,000</ENT>
                        <ENT>105,550</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.</P>
                <P>The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.</P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.</P>
                <P>For the reasons discussed, 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:</AMDPAR>
                <AMDPAR>a. Removing Airworthiness Directive 2018-11-01, Amendment 39-19289 (83 FR 23778, May 23, 2018); and</AMDPAR>
                <AMDPAR>b. Adding the following new airworthiness directive:</AMDPAR>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        <E T="04">Airbus Helicopters:</E>
                         Docket No. FAA-2021-0873; Project Identifier MCAI-2021-00336-R.
                    </FP>
                    <HD SOURCE="HD1">(a) Comments Due Date</HD>
                    <P>The FAA must receive comments on this airworthiness directive (AD) action by December 6, 2021.</P>
                    <HD SOURCE="HD1">(b) Affected ADs</HD>
                    <P>This AD replaces AD 2018-11-01, Amendment 39-19289 (83 FR 23778, May 23, 2018) (AD 2018-11-01).</P>
                    <HD SOURCE="HD1">(c) Applicability</HD>
                    <P>This AD applies to Airbus Helicopters Model AS332L2 and Model EC225LP helicopters, certificated in any category, as specified in paragraphs (c)(1) and (2) of this AD.</P>
                    <P>
                        (1) Model AS332L2 helicopters equipped with extended aluminum splices on frame 5295 installed in accordance with Airbus Helicopters (AH) Modification (MOD) 0726517, Eurocopter (EC) AS332 Service Bulletin (SB) 53.01.52, or AH repair design 332-53-507-06, 332-53-21-07, or 332-53-82-06; except helicopters embodying AH MOD 0728463, AH SB AS 332-53.01.97, or 
                        <PRTPAGE P="58603"/>
                        repair design 332-53-409-12, 332-53-1284-13, 332-53-1079-16, or 332-53-1358-16.
                    </P>
                    <P>
                        <E T="04">Note 1 to paragraph (c)(1):</E>
                         As referenced in paragraphs (c)(1) and (2) of this AD, helicopters with AH MOD 0728463 installed have replaced the aluminum splices with steel splices.
                    </P>
                    <P>(2) Model EC225LP helicopters equipped with extended aluminum splices on frame 5295 installed in accordance with AH MOD 0726517, or EC EC225 SB 53-003 (pre AH MOD 0726493 and post AH MOD 0726517), except helicopters embodying AH MOD 0728463, or SB EC225-53-061.</P>
                    <P>
                        <E T="04">Note 2 to paragraph (c)(2):</E>
                         Helicopters with AH MOD 0726493 have installed steel splice kit part number 332A08-2649-3072.
                    </P>
                    <HD SOURCE="HD1">(d) Subject</HD>
                    <P>Joint Aircraft Service Component (JASC) Code: 5300, Fuselage Structure.</P>
                    <HD SOURCE="HD1">(e) Unsafe Condition</HD>
                    <P>This AD was prompted by reports of cracks on frame 5295 and on aluminum splices installed to prevent those cracks. The FAA is issuing this AD to address cracking on frame 5295 and on the inner skins. The unsafe condition, if not addressed, could result in loss of structural integrity of the helicopter frame and subsequent loss of control of the helicopter.</P>
                    <HD SOURCE="HD1">(f) Compliance</HD>
                    <P>Comply with this AD within the compliance times specified, unless already done.</P>
                    <HD SOURCE="HD1">(g) Retained Installation and Inspections With New Service Information and Corrective Actions (Modification)</HD>
                    <P>This paragraph retains the requirements of paragraph (e) of AD 2018-11-01, with new service information and corrective actions (modification).</P>
                    <P>(1) Before a splice reaches 1,700 hours time-in-service (TIS), within 50 hours TIS, or before the helicopter reaches 11,950 hours TIS, whichever occurs latest, do the following.</P>
                    <P>(i) Install the rail support cut-out and identify the left-hand (LH) and right-hand (RH) junction profile, in accordance with the Accomplishment Instructions, paragraph 3.B.2., of Airbus Helicopters Alert Service Bulletin (ASB) No. EC225-05A038, Revision 1, dated February 9, 2021 (Airbus Helicopters ASB No. EC225-05A038, Revision 1); or Airbus Helicopters ASB No. AS332-05.00.97, Revision 1, dated February 9, 2021 (Airbus Helicopters ASB No. AS332-05.00.97, Revision 1); whichever is applicable to your helicopter.</P>
                    <P>(ii) Inspect each splice for a crack in the area depicted as Area Y in Figure 3 of Airbus Helicopters ASB No. EC225-05A038, Revision 1; or Airbus Helicopters ASB No. AS332-05.00.97, Revision 1; whichever is applicable to your helicopter. If a crack exists, do the applicable action required by paragraph (g)(1)(ii)(A) or (B) of this AD.</P>
                    <P>(A) For any cracking found before the effective date of this AD: Repair or replace the splice before further flight.</P>
                    <P>(B) For any cracking found on or after the effective date of this AD: Before further flight, modify the helicopter in accordance with paragraph 3.B.2. of the Accomplishment Instructions of Airbus Helicopters Service Bulletin (SB) No. AS332-53.01.97, Revision 0, dated February 9, 2021 (Airbus Helicopters SB No. AS332-53.01.97, Revision 0); or Service Bulletin No. EC225-53-061, Revision 0, dated February 9, 2021 (Airbus Helicopters SB No. EC225-53-061, Revision 0); as applicable to your helicopter; except as specified in paragraph (h) of this AD.</P>
                    <P>(2) Thereafter at intervals not to exceed 110 hours TIS, inspect each splice for a crack in the area depicted as Area Y in Figure 3 of Airbus Helicopters ASB No. EC225-05A038, Revision 1; or Airbus Helicopters ASB No. AS332-05.00.97, Revision 1; whichever is applicable to your helicopter. If a crack exists, do the applicable actions required by paragraph (g)(2)(i) or (ii) of this AD. Accomplishing the modification specified in paragraph (g)(1)(ii)(B) and (g)(2)(ii) of this AD terminates the inspections required by this paragraph.</P>
                    <P>(i) For any cracking found before the effective date of this AD: Repair or replace the splice before further flight.</P>
                    <P>(ii) For any cracking found on or after the effective date of this AD: Before further flight, modify the helicopter in accordance with paragraph 3.B.2. of the Accomplishment Instructions of Airbus Helicopters SB No. AS332-53.01.97, Revision 0; or Airbus Helicopters SB No. EC 225-53-061, Revision 0; as applicable to your helicopter; except as specified in paragraph (h) of this AD.</P>
                    <HD SOURCE="HD1">(h) Service Information Exceptions</HD>
                    <P>(1) Where Airbus Helicopters ASB No. EC225-05A038, Revision 1; Airbus Helicopters ASB No. AS332-05.00.97, Revision 1; Airbus Helicopters SB No. AS332-53.01.97, Revision 0; and Airbus Helicopters SB No. EC 225-53-061, Revision 0; specify to perform dye-penetrant inspections “if in doubt” or “if any doubt,” this AD requires performing a dye-penetrant inspection during inspections done on or after the effective date of this AD.</P>
                    <P>(2) Where Airbus Helicopters SB No. AS332-53.01.97, Revision 0; and Airbus Helicopters SB No. EC 225-53-061, Revision 0; specify discarding parts, this AD requires removing those parts from service.</P>
                    <P>(3) Where Airbus Helicopters SB No. AS332-53.01.97, Revision 0; and Airbus Helicopters SB No. EC 225-53-061, Revision 0, specify contacting Airbus Helicopter for corrective action or further procedures, this AD requires repair done in accordance with a method approved by the Manager, General Aviation &amp; Rotorcraft Section, International Validation Branch, FAA; or EASA; or Airbus Helicopters' EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.</P>
                    <P>(4) Airbus Helicopters SB No. AS332-53.01.97, Revision 0; and Airbus Helicopters SB No. EC 225-53-061, Revision 0, specify a visual check and dye penetrant inspection for cracks on the inside and outside of frame 5295. For this AD, if any cracking is found during any visual check or dye penetrant inspection on the inside and outside of frame 5295, before further flight, repair in accordance with a method approved by the Manager, General Aviation &amp; Rotorcraft Section, International Validation Branch, FAA; or EASA; or Airbus Helicopters' EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.</P>
                    <HD SOURCE="HD1">(i) Reporting Not Required</HD>
                    <P>Although Airbus Helicopters SB No. AS332-53.01.97, Revision 0; and Airbus Helicopters SB No. EC 225-53-061, Revision 0; specify to submit certain information to the manufacturer, this AD does not include that requirement.</P>
                    <HD SOURCE="HD1">(j) Credit for Previous Actions</HD>
                    <P>(1) This paragraph provides credit for the installation of the rail support cut-out required by paragraph (g)(1)(i) of this AD, if that action was performed before June 27, 2018 (the effective date of AD 2018-11-01) using Airbus Helicopters MOD 0728090 or Airbus Helicopters SB No. 05-019, Revision 4, dated September 22, 2014.</P>
                    <P>(2) This paragraph provides credit for the actions required by paragraphs (g)(1) and (2) of this AD, if the actions were performed before the effective date of this AD using Airbus Helicopters ASB No. EC225-05A038, Revision 0, dated April 15, 2014; or Airbus Helicopters ASB No. AS332-05.00.97, Revision 0, dated April 15, 2014.</P>
                    <HD SOURCE="HD1">(k) Special Flight Permits</HD>
                    <P>Special flight permits may be issued in accordance with 14 CFR 21.197 and 21.199 to operate the helicopter to a location where the actions can be performed, provided no passengers are onboard.</P>
                    <HD SOURCE="HD1">(l) Alternative Methods of Compliance (AMOCs)</HD>
                    <P>
                        (1) The Manager, International Validation Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the International Validation Branch, send it to the attention of the person identified in paragraph (m)(1) of this AD. Information may be emailed to: 
                        <E T="03">9-AVS-AIR-730-AMOC@faa.gov.</E>
                    </P>
                    <P>(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.</P>
                    <HD SOURCE="HD1">(m) Related Information</HD>
                    <P>
                        (1) For more information about this AD, contact Andrea Jimenez, Aerospace Engineer, COS Program Management Section, Operational Safety Branch, Compliance &amp; Airworthiness Division, FAA, 1600 Stewart Ave., Suite 410, Westbury, NY 11590; telephone (516) 228-7330; email 
                        <E T="03">andrea.jimenez@faa.gov.</E>
                    </P>
                    <P>
                        (2) For service information identified in this AD, contact Airbus Helicopters, 2701 North Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at 
                        <E T="03">https://www.airbus.com/helicopters/services/technical-support.html.</E>
                         You may view this 
                        <PRTPAGE P="58604"/>
                        referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110.
                    </P>
                    <P>
                        (3) The subject of this AD is addressed in European Union Aviation Safety Agency (EASA) AD 2021-0075, dated March 16, 2021. You may view the EASA AD on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         in Docket No. FAA-2021-0873.
                    </P>
                </EXTRACT>
                <SIG>
                    <DATED>Issued on October 4, 2021.</DATED>
                    <NAME>Lance T. Gant,</NAME>
                    <TITLE>Director, Compliance &amp; Airworthiness Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-22462 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 71</CFR>
                <DEPDOC>[Docket No. FAA-2021-0851; Airspace Docket No. 19-AAL-42]</DEPDOC>
                <RIN>RIN 2120-AA66</RIN>
                <SUBJECT>Proposed Establishment of United States Area Navigation (RNAV) Route T-373; Bethel, AK</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking (NPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This action proposes to establish United States Area Navigation (RNAV) route T-373 in the vicinity of Bethel, AK in support of a large and comprehensive T-route modernization project for the state of Alaska.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before December 6, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1(800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2021-0851; Airspace Docket No. 19-AAL-42 at the beginning of your comments. You may also submit comments through the internet at 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                    <P>
                        FAA Order JO 7400.11F, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at 
                        <E T="03">https://www.faa.gov/air_traffic/publications/.</E>
                         For further information, you can contact the Rules and Regulations Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783. FAA Order JO 7400.11F is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order JO 7400.11F at NARA, email: 
                        <E T="03">fr.inspection@nara.gov</E>
                         or go to 
                        <E T="03">https://www.archives.gov/federal-register/cfr/ibr-locations.html.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Christopher McMullin, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would expand the availability of RNAV in Alaska and improve the efficient flow of air traffic within the National Airspace System (NAS) by lessening the dependency on ground based navigation.</P>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.</P>
                <P>
                    Communications should identify both docket numbers (FAA Docket No. FAA-2021-0851; Airspace Docket No. 19-AAL-42) and be submitted in triplicate to the Docket Management Facility (see 
                    <E T="02">ADDRESSES</E>
                     section for address and phone number). You may also submit comments through the internet at 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <P>Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2021-0851; Airspace Docket No. 19-AAL-42”. The postcard will be date/time stamped and returned to the commenter.</P>
                <P>All communications received on or before the specified comment closing date will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.</P>
                <HD SOURCE="HD1">Availability of NPRM</HD>
                <P>
                    An electronic copy of this document may be downloaded through the internet at 
                    <E T="03">https://www.regulations.gov.</E>
                     Recently published rulemaking documents can also be accessed through the FAA's web page at 
                    <E T="03">https://www.faa.gov/air_traffic/publications/airspace_amendments/.</E>
                </P>
                <P>
                    You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see 
                    <E T="02">ADDRESSES</E>
                     section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays. An informal docket may also be examined during normal business hours at the office of the Western Service Center, Operations Support Group, Federal Aviation Administration, 2200 South 216th St., Des Moines, WA 98198.
                </P>
                <HD SOURCE="HD1">Availability and Summary of Documents for Incorporation by Reference</HD>
                <P>
                    This document proposes to amend FAA Order JO 7400.11F, Airspace Designations and Reporting Points, dated August 10, 2021, and effective September 15, 2021. FAA Order JO 7400.11F is publicly available as listed in the 
                    <E T="02">ADDRESSES</E>
                     section of this document. FAA Order JO 7400.11F lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    In 2003, Congress enacted the Vision 100-Century of Aviation Reauthorization Act (Pub L., 108-176), which established a joint planning and development office in the FAA to manage the work related to the Next Generation Air Transportation System (NextGen). Today, NextGen is an 
                    <PRTPAGE P="58605"/>
                    ongoing FAA-led modernization of the nation's air transportation system to make flying safer, more efficient, and more predictable.
                </P>
                <P>
                    In support of NextGen, this proposal is part of a larger and comprehensive T-route modernization project in the state of Alaska. The project mission statement states: “To modernize Alaska's Air Traffic Service route structure using satellite based navigation Development of new T-routes and optimization of existing T-routes will enhance safety, increase efficiency and access, and will provide en route continuity that is not subject to the restrictions associated with ground based airway navigation.” As part of this project, the FAA evaluated the existing Colored Airway structure for: (a) Direct replacement (
                    <E T="03">i.e.,</E>
                     overlay) with a T-route that offers a similar or lower Minimum En route Altitude (MEA) or Global Navigation Satellite System Minimum En route Altitude (GNSS MEA); (b) the replacement of the colored airway with a T-route in an optimized but similar geographic area, while retaining similar or lower MEA; or (c) removal with no route structure (T-route) restored in that area because the value was determined to be insignificant.
                </P>
                <P>The aviation industry/users have indicated a desire for the FAA to transition the Alaskan en route navigation structure away from dependency on Non-Directional Beacons (NDB), and move to develop and improve the RNAV route structure. The FAA proposes to establish RNAV route T-373 to provide an alternate routing for Colored Federal airways B-27 and R-50. The proposed route allows for a lower GNSS MEA, and would support pending decommissioning of NDBs while providing RNAV alternates to Oscarville, AK, (OSE) and Anvik, AK, (ANV) NDBs.</P>
                <HD SOURCE="HD1">The Proposal</HD>
                <P>The FAA is proposing an amendment to 14 CFR part 71 to establish RNAV route T-373 in the vicinity of Bethel, AK in support of a large and comprehensive T-route modernization project for the state of Alaska. The proposed route is described below.</P>
                <P>
                    <E T="03">T-373:</E>
                     The FAA proposes to establish T-373 from the KOWOK, AK, Fix, northeast of the Dillingham, AK, (DLG) waypoint (WP) to the WEREL, AK, WP, which would be the GNSS WP for ANV.
                </P>
                <P>United States Area Navigation Routes are published in paragraph 6011 of FAA Order JO 7400.11F dated August 10, 2021 and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The RNAV listed in this document would be published subsequently in FAA Order JO 7400.11F.</P>
                <P>FAA Order JO 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.</P>
                <HD SOURCE="HD1">Regulatory Notices and Analyses</HD>
                <P>The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.</P>
                <HD SOURCE="HD1">Environmental Review</HD>
                <P>This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 71</HD>
                    <P>Airspace, Incorporation by reference, Navigation (air).</P>
                </LSTSUB>
                <HD SOURCE="HD1">The Proposed Amendment</HD>
                <P>In consideration of the foregoing, the Federal Aviation Administration proposes to  amend 14 CFR part 71 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 71 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 71.1</SECTNO>
                    <SUBJECT> [Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO 7400.11F, Airspace Designations and Reporting Points, dated August 10, 2021, and effective September 15, 2021, is amended as follows:</AMDPAR>
                <EXTRACT>
                    <HD SOURCE="HD2">Paragraph 6011 United States Area Navigation Routes.</HD>
                    <STARS/>
                    <GPOTABLE COLS="3" OPTS="L0,tp0,p0,7/8,g1,t1,i1" CDEF="xls80,xls50,xls180">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1"> </CHED>
                            <CHED H="1"> </CHED>
                        </BOXHD>
                        <ROW EXPSTB="02">
                            <ENT I="22">
                                <E T="04">T-373 KOWOK, AK to WEREL, AK [New]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">KOWOK, AK</ENT>
                            <ENT>FIX</ENT>
                            <ENT>(Lat. 59°12′31.22″ N, long. 157°50′52.40″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">RAGES, AK</ENT>
                            <ENT>FIX</ENT>
                            <ENT>(Lat. 59°21′43.36″ N, long. 158°12′22.14″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">ZUDSO, AK</ENT>
                            <ENT>WP</ENT>
                            <ENT>(Lat. 59°48′13.53″ N, long. 158°57′43.10″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">MAYHW, AK</ENT>
                            <ENT>WP</ENT>
                            <ENT>(Lat. 59°48′11.94″ N, long. 159°16′08.97″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">FEXOP, AK</ENT>
                            <ENT>WP</ENT>
                            <ENT>(Lat. 60°15′14.46″ N, long. 160°07′38.69″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">BETHEL, AK (BET)</ENT>
                            <ENT>VORTAC</ENT>
                            <ENT>(Lat. 60°47′05.41″ N, long. 161°49′27.59″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">WEREL, AK</ENT>
                            <ENT>WP</ENT>
                            <ENT>(Lat. 62°38′29.25″ N, long. 160°11′07.20″ W)</ENT>
                        </ROW>
                    </GPOTABLE>
                </EXTRACT>
                <STARS/>
                <SIG>
                    <DATED>Issued in Washington, DC, on October 14, 2021.</DATED>
                    <NAME>Michael R. Beckles,</NAME>
                    <TITLE>Acting Manager, Rules and Regulations Group.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-22675 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <PRTPAGE P="58606"/>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 71</CFR>
                <DEPDOC>[Docket No. FAA-2021-0854; Airspace Docket No. 20-AAL-54]</DEPDOC>
                <RIN>RIN 2120-AA66</RIN>
                <SUBJECT>Proposed Revocation of Federal Colored Airway B-25; Gulkana, AK</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking (NPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This action proposes to revoke Colored Federal airway, B-25. The revocation is necessary due to the planned decommissioning of the Glenallen Non-Directional Beacon (NDB) Gulkana, AK, which provides navigation guidance for the affected route. The Glenallen NDB is to be decommissioned effective September 8, 2022 due to the high cost of maintenance.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before December 6, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1(800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2021-0854; Airspace Docket No. 20-AAL-54 at the beginning of your comments. You may also submit comments through the internet at 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                    <P>
                        FAA Order JO 7400.11F, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at 
                        <E T="03">https://www.faa.gov/air_traffic/publications/.</E>
                         For further information, you can contact the Rules and Regulations Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783. FAA Order JO 7400.11F is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order JO 7400.11F at NARA, email: 
                        <E T="03">fr.inspection@nara.gov</E>
                         or go to 
                        <E T="03">https://www.archives.gov/federal-register/cfr/ibr-locations.html.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Christopher McMullin, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would modify the route structure as necessary to preserve the safe and efficient flow of air traffic within the National Airspace System.</P>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. </P>
                <P>
                    Communications should identify both docket numbers (FAA Docket No. FAA-2021-0854; Airspace Docket No. 20-AAL-54) and be submitted in triplicate to the Docket Management Facility (see 
                    <E T="02">ADDRESSES</E>
                     section for address and phone number). You may also submit comments through the internet at 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <P>Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2021-0854; Airspace Docket No. 20-AAL-54.” The postcard will be date/time stamped and returned to the commenter.</P>
                <P>All communications received on or before the specified comment closing date will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.</P>
                <HD SOURCE="HD1">Availability of NPRMs</HD>
                <P>
                    An electronic copy of this document may be downloaded through the internet at 
                    <E T="03">https://www.regulations.gov.</E>
                     Recently published rulemaking documents can also be accessed through the FAA's web page at 
                    <E T="03">https://www.faa.gov/air_traffic/publications/airspace_amendments/.</E>
                </P>
                <P>
                    You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see 
                    <E T="02">ADDRESSES</E>
                     section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays. An informal docket may also be examined during normal business hours at the office of the Western Service Center, Operations Support Group, Federal Aviation Administration, 2200 South 216th St., Des Moines, WA 98198.
                </P>
                <HD SOURCE="HD1">Availability and Summary of Documents for Incorporation by Reference</HD>
                <P>
                    This document proposes to amend FAA Order JO 7400.11F, Airspace Designations and Reporting Points, dated August 10,202, and effective September 15, 2021. FAA Order JO 7400.11F is publicly available as listed in the 
                    <E T="02">ADDRESSES</E>
                     section of this document. FAA Order JO 7400.11F lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>Due to the high cost of maintenance, and the FAA's move toward Global Navigation Satellite System-based navigation, a decision was made to remove the Glenallen NDB (GLA) from service. This action will require revocation of Colored Federal Airway B-25.</P>
                <P>Colored Federal airway B-25 will be unusable due to the pending decommissioning of GLA. The loss of B-25 can be mitigated by utilizing Area Navigation (RNAV) route T-226 or VHF Omnidirectional Range (VOR) route V-481.</P>
                <HD SOURCE="HD1">The Proposal</HD>
                <P>The FAA is proposing an amendment to 14 CFR part 71 to revoke Colored Federal airway B-25. The proposed actions are described below.</P>
                <P>
                    <E T="03">B-25:</E>
                     B-25 currently extends between the Orca Bay, AK, NDB and the Delta Junction, AK, NDB. The FAA proposes to remove the entire route.
                    <PRTPAGE P="58607"/>
                </P>
                <P>Colored Federal airways are published in paragraph 6009 of FAA Order JO 7400.11F dated August 10, 2021, and effective September 15, 2020, which is incorporated by reference in 14 CFR part 71.1. The Colored Federal Airway listed in this document will be subsequently be removed from FAA Order JO 7400.11F.</P>
                <P>FAA Order JO 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.</P>
                <HD SOURCE="HD1">Regulatory Notices and Analyses</HD>
                <P>The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.</P>
                <HD SOURCE="HD1">Environmental Review</HD>
                <P>This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 71</HD>
                    <P>Airspace, Incorporation by reference, Navigation (air).</P>
                </LSTSUB>
                <HD SOURCE="HD1">The Proposed Amendment</HD>
                <P>In consideration of the foregoing, the Federal Aviation Administration proposes to  amend 14 CFR part 71 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 71 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 71.1</SECTNO>
                    <SUBJECT> [Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO 7400.11F, Airspace Designations and Reporting Points, dated August 10, 2021 and effective September 15, 2021, is amended as follows:</AMDPAR>
                <EXTRACT>
                    <HD SOURCE="HD2">Paragraph 6009—Colored Federal Airways</HD>
                    <STARS/>
                    <HD SOURCE="HD1">B-25 [Removed]</HD>
                </EXTRACT>
                <STARS/>
                <SIG>
                    <DATED>Issued in Washington, DC, on October 14, 2021.</DATED>
                    <NAME>Michael R. Beckles,</NAME>
                    <TITLE>Acting Manager, Rules and Regulations Group.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-22585 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 71</CFR>
                <DEPDOC>[Docket No. FAA-2017-0438; Airspace Docket No. 17-AEA-5]</DEPDOC>
                <RIN>RIN 2120-AA66</RIN>
                <SUBJECT>Proposed Amendment VOR Federal Airways V-66, V-189, V-260, and V-266; in the Vicinity of Franklin, VA</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); withdrawal.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The FAA is withdrawing the NPRM published in the 
                        <E T="04">Federal Register</E>
                         on June 2, 2017, proposing to modify VHF Omnidirectional Range (VOR) Federal airways V-66, V-189, V-260, and V-266 in the Vicinity of Franklin, VA, due to the planned decommissioning of the Franklin, VA, (FKN) VOR and Tactical Air Navigational System (VORTAC) navigation aid. Subsequent to the NPRM, the FKN VORTAC decommissioning has been delayed until a to-be-determined date. The FAA decided that additional planning is necessary to ensure a more efficient implementation and integration with other ongoing VOR Minimum Operational Network (VOR MON) program activities, and determined that withdrawal of the proposed rule is warranted.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective October 22, 2021, the proposed rule published June 2, 2017 (82 FR 25559), is withdrawn.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Paul Gallant, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">History</HD>
                <P>
                    The FAA published a notice of proposed rulemaking in the 
                    <E T="04">Federal Register</E>
                     for Docket No. FAA-2017-0438 (82 FR 25559; June 2, 2017). The NPRM proposed to amend VOR Federal airways V-66, V-189, V-260, and V-266 due to the planned decommissioning of the FKN VORTAC which provides navigation guidance for portions of the affected airways. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. One comment was received. The commenter recommended that, for VOR NAVAIDs that are to be decommissioned, and for those airways that are correspondingly removed, the FAA should create an area navigation (RNAV) waypoint at the previous NAVAID location, and convert all fixes and intersections along that route to RNAV waypoints.
                </P>
                <HD SOURCE="HD1">FAA's Conclusions</HD>
                <P>The FAA has reviewed the FKN VORTAC decommissioning project and determined that additional planning meetings are warranted to ensure a more efficient implementation and integration with other ongoing program activities; therefore, the NPRM is withdrawn.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 71</HD>
                    <P>Airspace, Incorporation by reference, Navigation (air).</P>
                </LSTSUB>
                <HD SOURCE="HD1">The Withdrawal</HD>
                <AMDPAR>
                    Accordingly, pursuant to the authority delegated to me, the NPRM published in the 
                    <E T="04">Federal Register</E>
                     on June 2, 2017 (82 FR 25559), FR Doc. 2017-11080, is hereby withdrawn.
                </AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854; 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.</P>
                </AUTH>
                <SIG>
                    <DATED>Issued in Washington, DC, on October 14, 2021.</DATED>
                    <NAME>Michael R. Beckles,</NAME>
                    <TITLE>Acting Manager, Rules and Regulations Group.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-22676 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <PRTPAGE P="58608"/>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 71</CFR>
                <DEPDOC>[Docket No. FAA-2021-0819; Airspace Docket No. 19-AAL-37]</DEPDOC>
                <RIN>RIN 2120-AA66</RIN>
                <SUBJECT>Proposed Establishment of United States Area Navigation (RNAV) Route T-368; King Salmon, AK</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking (NPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This action proposes to establish United States Area Navigation (RNAV) route T-368 in the vicinity of King Salmon, AK in support of a large and comprehensive T-route modernization project for the state of Alaska.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before December 6, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1 (800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2021-0819; Airspace Docket No. 19-AAL-37 at the beginning of your comments. You may also submit comments through the internet at 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                    <P>
                        FAA Order JO 7400.11F, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at 
                        <E T="03">https://www.faa.gov/air_traffic/publications/.</E>
                         For further information, you can contact the Rules and Regulations Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783. FAA Order JO 7400.11F is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order JO 7400.11F at NARA, email: 
                        <E T="03">fr.inspection@nara.gov</E>
                         or go to 
                        <E T="03">https://www.archives.gov/federal-register/cfr/ibr-locations.html.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Christopher McMullin, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would expand the availability of RNAV in Alaska and improve the efficient flow of air traffic within the National Airspace System (NAS) by lessening the dependency on ground based navigation.</P>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.</P>
                <P>
                    Communications should identify both docket numbers (FAA Docket No. FAA-2021-0819; Airspace Docket No. 19-AAL-37) and be submitted in triplicate to the Docket Management Facility (see 
                    <E T="02">ADDRESSES</E>
                     section for address and phone number). You may also submit comments through the internet at 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <P>Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2021-0819; Airspace Docket No. 19-AAL-37.” The postcard will be date/time stamped and returned to the commenter.</P>
                <P>All communications received on or before the specified comment closing date will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.</P>
                <HD SOURCE="HD1">Availability of NPRM</HD>
                <P>
                    An electronic copy of this document may be downloaded through the internet at 
                    <E T="03">https://www.regulations.gov.</E>
                     Recently published rulemaking documents can also be accessed through the FAA's web page at 
                    <E T="03">https://www.faa.gov/air_traffic/publications/airspace_amendments/.</E>
                </P>
                <P>
                    You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see 
                    <E T="02">ADDRESSES</E>
                     section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays. An informal docket may also be examined during normal business hours at the office of the Western Service Center, Operations Support Group, Federal Aviation Administration, 2200 South 216th St., Des Moines, WA 98198.
                </P>
                <HD SOURCE="HD1">Availability and Summary of Documents for Incorporation by Reference</HD>
                <P>
                    This document proposes to amend FAA Order JO 7400.11F, Airspace Designations and Reporting Points, dated August 10, 2021, and effective September 15, 2021. FAA Order JO 7400.11F is publicly available as listed in the 
                    <E T="02">ADDRESSES</E>
                     section of this document. FAA Order JO 7400.11F lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>In 2003, Congress enacted the Vision 100-Century of Aviation Reauthorization Act (Pub. L., 108-176), which established a joint planning and development office in the FAA to manage the work related to the Next Generation Air Transportation System (NextGen). Today, NextGen is an ongoing FAA-led modernization of the nation's air transportation system to make flying safer, more efficient, and more predictable.</P>
                <P>
                    In support of NextGen, this proposal is part of a larger and comprehensive T-route modernization project in the state of Alaska. The project mission statement states: “To modernize Alaska's Air Traffic Service route structure using satellite based navigation Development of new T-routes and optimization of existing T-routes will enhance safety, increase efficiency and access, and will provide en route continuity that is not subject to the restrictions associated 
                    <PRTPAGE P="58609"/>
                    with ground based airway navigation.” As part of this project, the FAA evaluated the existing Colored Airway structure for: (a) Direct replacement (
                    <E T="03">i.e.,</E>
                     overlay) with a T-route that offers a similar or lower Minimum En route Altitude (MEA) or Global Navigation Satellite System Minimum En route Altitude (GNSS MEA); (b) the replacement of the colored airway with a T-route in an optimized but similar geographic area, while retaining similar or lower MEA; or (c) removal with no route structure (T-route) restored in that area because the value was determined to be insignificant.
                </P>
                <P>The aviation industry/users have indicated a desire for the FAA to transition the Alaskan en route navigation structure away from dependency on Non-Directional Beacons (NDB), and move to develop and improve the RNAV route structure. The FAA proposes to establish RNAV route T-368 to provide an alternate routing for Alaskan VHF Omnidirectional range (VOR) Federal airway V-506 between King Salmon, AK, (AKN) VOR and tactical air navigation system (VORTAC) and Kodiak, AK, (ODK) VOR. Currently, V-506 in this area is unusable beyond 20 nautical miles from ODK below 12,000 feet due to the Minimum Reception Altitude (MRA) of ground-based navigational aids (NAVAIDS). The proposal would provide an RNAV route that ensures adequate continuous two-way VHF communications. Additionally, the proposed T-368 would allow for an alternative to Colored Federal airway B-27, which utilizes Chinook, AK, (AUB) NDB scheduled for decommissioning.</P>
                <HD SOURCE="HD1">The Proposal</HD>
                <P>The FAA is proposing an amendment to 14 CFR part 71 to establish RNAV route T-368 in the vicinity of King Salmon, AK in support of a large and comprehensive T-route modernization project for the state of Alaska. The proposed route is described below.</P>
                <P>
                    <E T="03">T-368:</E>
                     The FAA proposes to establish T-368 from AKN to ODK as an alternative to V-506 and B-27.
                </P>
                <P>United States Area Navigation Routes are published in paragraph 6011 of FAA Order JO 7400.11F dated August 10, 2021 and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The RNAV route listed in this document would be published subsequently in FAA Order JO 7400.11F.</P>
                <P>FAA Order JO 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.</P>
                <HD SOURCE="HD1">Regulatory Notices and Analyses</HD>
                <P>The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.</P>
                <HD SOURCE="HD1">Environmental Review</HD>
                <P>This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 71</HD>
                    <P>Airspace, Incorporation by reference, Navigation (air).</P>
                </LSTSUB>
                <HD SOURCE="HD1">The Proposed Amendment</HD>
                <P>In consideration of the foregoing, the Federal Aviation Administration proposes to  amend 14 CFR part 71 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 71 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 71.1</SECTNO>
                    <SUBJECT> [Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO 7400.11F, Airspace Designations and Reporting Points, dated August 10, 2021, and effective September 15, 2021, is amended as follows:</AMDPAR>
                <EXTRACT>
                    <HD SOURCE="HD2">Paragraph 6011 United States Area Navigation Routes</HD>
                    <STARS/>
                    <GPOTABLE COLS="3" OPTS="L0,tp0,p0,7/8,g1,t1,i1" CDEF="xls110,xls50,xls180">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1"> </CHED>
                            <CHED H="1"> </CHED>
                        </BOXHD>
                        <ROW EXPSTB="02">
                            <ENT I="22">
                                <E T="04">T-368 King Salmon, AK to Kodiak, AK [New]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">KING SALMON, AK (AKN)</ENT>
                            <ENT>VORTAC </ENT>
                            <ENT>(Lat. 58°43′28.97″ N, long. 156°45′08.45″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">KOKOZ, AK</ENT>
                            <ENT>FIX </ENT>
                            <ENT>(Lat. 58°31′05.99″ N, long. 155°42′32.17″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">WORRI, AK</ENT>
                            <ENT>FIX </ENT>
                            <ENT>(Lat. 58°45′58.43″ N, long. 154°10′05.90″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CIXUL, AK</ENT>
                            <ENT>WP </ENT>
                            <ENT>(Lat. 58°43′04.78″ N, long. 153°25′52.53″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">OSBOE, AK</ENT>
                            <ENT>FIX </ENT>
                            <ENT>(Lat. 57°48′07.57″ N, long. 152°27′12.75″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">KODIAK, AK (ODK)</ENT>
                            <ENT>VOR/DME </ENT>
                            <ENT>(Lat. 57°46′30.13″ N, long. 152°20′23.42″ W)</ENT>
                        </ROW>
                    </GPOTABLE>
                </EXTRACT>
                <STARS/>
                <SIG>
                    <DATED>Issued in Washington, DC, on October 12, 2021.</DATED>
                    <NAME>Michael R. Beckles,</NAME>
                    <TITLE>Acting Manager, Rules and Regulations Group.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-22586 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 71</CFR>
                <DEPDOC>[Docket No. FAA-2021-0848; Airspace Docket No. 19-AAL-41]</DEPDOC>
                <RIN>RIN 2120-AA66</RIN>
                <SUBJECT>Proposed Amendment of United States Area Navigation (RNAV) Route T-372; Gulkana, AK</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking (NPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This action proposes to amend United States Area Navigation (RNAV) route T-372 in the vicinity of Gulkana, AK in support of a large and comprehensive T-route modernization project for the state of Alaska.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before December 6, 2021</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building 
                        <PRTPAGE P="58610"/>
                        Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1(800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2021-0848; Airspace Docket No. 19-AAL-41 at the beginning of your comments. You may also submit comments through the internet at 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                    <P>
                        FAA Order JO 7400.11F, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at 
                        <E T="03">https://www.faa.gov/air_traffic/publications/.</E>
                         For further information, you can contact the Rules and Regulations Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783. FAA Order JO 7400.11F is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order JO 7400.11F at NARA, email: 
                        <E T="03">fr.inspection@nara.gov</E>
                         or go to 
                        <E T="03">https://www.archives.gov/federal-register/cfr/ibr-locations.html.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Christopher McMullin, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would expand the availability of RNAV in Alaska and improve the efficient flow of air traffic within the National Airspace System (NAS) by lessening the dependency on ground based navigation.</P>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.</P>
                <P>
                    Communications should identify both docket numbers (FAA Docket No. FAA-2021-0848; Airspace Docket No. 19-AAL-41) and be submitted in triplicate to the Docket Management Facility (see 
                    <E T="02">ADDRESSES</E>
                     section for address and phone number). You may also submit comments through the internet at 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <P>Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2021-0848; Airspace Docket No. 19-AAL-41.” The postcard will be date/time stamped and returned to the commenter.</P>
                <P>All communications received on or before the specified comment closing date will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.</P>
                <HD SOURCE="HD1">Availability of NPRM</HD>
                <P>
                    An electronic copy of this document may be downloaded through the internet at 
                    <E T="03">https://www.regulations.gov.</E>
                     Recently published rulemaking documents can also be accessed through the FAA's web page at 
                    <E T="03">https://www.faa.gov/air_traffic/publications/airspace_amendments/.</E>
                </P>
                <P>
                    You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see 
                    <E T="02">ADDRESSES</E>
                     section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays. An informal docket may also be examined during normal business hours at the office of the Western Service Center, Operations Support Group, Federal Aviation Administration, 2200 South 216th St., Des Moines, WA 98198.
                </P>
                <HD SOURCE="HD1">Availability and Summary of Documents for Incorporation by Reference</HD>
                <P>
                    This document proposes to amend FAA Order JO 7400.11F, Airspace Designations and Reporting Points, dated August 10, 2021, and effective September 15, 2021. FAA Order JO 7400.11F is publicly available as listed in the 
                    <E T="02">ADDRESSES</E>
                     section of this document. FAA Order JO 7400.11F lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>In 2003, Congress enacted the Vision 100-Century of Aviation Reauthorization Act (Pub. L., 108-176), which established a joint planning and development office in the FAA to manage the work related to the Next Generation Air Transportation System (NextGen). Today, NextGen is an ongoing FAA-led modernization of the nation's air transportation system to make flying safer, more efficient, and more predictable.</P>
                <P>
                    In support of NextGen, this proposal is part of a larger and comprehensive T-route modernization project in the state of Alaska. The project mission statement states: “To modernize Alaska's Air Traffic Service route structure using satellite based navigation Development of new T-routes and optimization of existing T-routes will enhance safety, increase efficiency and access, and will provide enroute continuity that is not subject to the restrictions associated with ground based airway navigation.” As part of this project, the FAA evaluated the existing Colored Airway structure for: (a) Direct replacement (
                    <E T="03">i.e.,</E>
                     overlay) with a T-route that offers a similar or lower Minimum En route Altitude (MEA) or Global Navigation Satellite System Minimum En route Altitude (GNSS MEA); (b) the replacement of the colored airway with a T-route in an optimized but similar geographic area, while retaining similar or lower MEA; or (c) removal with no route structure (T-route) restored in that area because the value was determined to be insignificant.
                </P>
                <P>
                    The aviation industry/users have indicated a desire for the FAA to transition the Alaskan enroute navigation structure away from dependency on Non-Directional Beacons (NDB), and move to develop and improve the RNAV route structure. The FAA proposes to establish RNAV route T-372 to provide an alternate routing for Colored Federal airways A-2, G-11, and A-15. The FAA published a final rule in the 
                    <E T="04">Federal Register</E>
                     (85 FR 59668; September 23, 2020) removing Colored Federal airway G-11 due to the decommissioning of the Campbell Lake NDB. This route provided an alternate to VHF Omnidirectional Range (VOR) Federal 
                    <PRTPAGE P="58611"/>
                    airway V-456 and allowed for a generally lower MEA. This proposal would provide a similar routing to the previous G-11 and reestablish an alternate to V-456. Additionally, the proposed T-372 would provide instrument approach connectivity to Gulkana airport (PAGK).
                </P>
                <HD SOURCE="HD1">The Proposal</HD>
                <P>The FAA is proposing an amendment to 14 CFR part 71 to establish RNAV route T-372 in the vicinity of Gulkana, AK in support of a large and comprehensive T-route modernization project for the state of Alaska. The proposed route is described below.</P>
                <P>
                    <E T="03">T-372:</E>
                     The FAA proposes to establish T-372 from the Big Lake, AK, (BGQ) VOR/Tactical Air Navigation (VORTAC) to the OLARU, AK, Fix, on the Canadian border south east of Northway, AK (ORT).
                </P>
                <P>United States Area Navigation Routes are published in paragraph 6011 of FAA Order JO 7400.11F dated August 10, 2021 and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The RNAV listed in this document would be published subsequently in FAA Order JO 7400.11F.</P>
                <P>FAA Order JO 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.</P>
                <HD SOURCE="HD1">Regulatory Notices and Analyses</HD>
                <P>The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.</P>
                <HD SOURCE="HD1">Environmental Review</HD>
                <P>This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 71</HD>
                    <P>Airspace, Incorporation by reference, Navigation (air).</P>
                </LSTSUB>
                <HD SOURCE="HD1">The Proposed Amendment</HD>
                <P>In consideration of the foregoing, the Federal Aviation Administration proposes to  amend 14 CFR part 71 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 71 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 71.1</SECTNO>
                    <SUBJECT> [Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO 7400.11F, Airspace Designations and Reporting Points, dated August 10, 2021, and effective September 15, 2021, is amended as follows:</AMDPAR>
                <EXTRACT>
                    <HD SOURCE="HD2">Paragraph 6011 United States Area Navigation Routes.</HD>
                    <STARS/>
                    <GPOTABLE COLS="3" OPTS="L0,tp0,p0,7/8,g1,t1,i1" CDEF="xls80,xls50,xls180">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1"> </CHED>
                            <CHED H="1"> </CHED>
                        </BOXHD>
                        <ROW EXPSTB="02">
                            <ENT I="22">
                                <E T="04">T-372 Big Lake, AK to OLARU, AK [New]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">BIG LAKE, AK (BGQ) </ENT>
                            <ENT>VORTAC </ENT>
                            <ENT>(Lat. 61°34′09.96″ N, long. 149°58′01.77″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">WUNTU, AK </ENT>
                            <ENT>WP </ENT>
                            <ENT>(Lat. 61°39′45.05″ N, long. 149°01′19.62″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CAGOP, AK </ENT>
                            <ENT>WP </ENT>
                            <ENT>(Lat. 61°45′11.32″ N, long. 148°41′36.03″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">FITAT, AK </ENT>
                            <ENT>WP </ENT>
                            <ENT>(Lat. 61°48′13.09″ N, long. 148°25′58.83″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">TOYOC, AK </ENT>
                            <ENT>WP </ENT>
                            <ENT>(Lat. 61°50′01.83″ N, long. 148°09′21.18″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">ZAMUP, AK </ENT>
                            <ENT>WP </ENT>
                            <ENT>(Lat. 61°50′11.52″ N, long. 148°00′30.00″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CANGI, AK </ENT>
                            <ENT>WP </ENT>
                            <ENT>(Lat. 61°49′36.38″ N, long. 147°49′10.69″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">WAPRU, AK </ENT>
                            <ENT>WP </ENT>
                            <ENT>(Lat. 61°53′10.56″ N, long. 147°24′11.32″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">HOSON, AK </ENT>
                            <ENT>WP </ENT>
                            <ENT>(Lat. 61°55′03.32″ N, long. 147°12′53.20″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">SMOKY, AK </ENT>
                            <ENT>WP </ENT>
                            <ENT>(Lat. 62°03′19.52″ N, long. 146°18′31.81″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">GULKANA, AK (GKN)</ENT>
                            <ENT> VOR/DME </ENT>
                            <ENT>(Lat. 62°09′13.51″ N, long. 145°26′50.51″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">BEFTI, AK </ENT>
                            <ENT>WP </ENT>
                            <ENT>(Lat. 62°33′28.06″ N, long. 144°27′09.48″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CEBUN, AK </ENT>
                            <ENT>WP </ENT>
                            <ENT>(Lat. 62°38′09.30″ N, long. 144°16′27.61″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">NORTHWAY, AK (ORT) </ENT>
                            <ENT>VORTAC </ENT>
                            <ENT>(Lat. 62°56′49.92″ N, long. 141°54′45.39″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">OLARU, AK </ENT>
                            <ENT>FIX </ENT>
                            <ENT>(Lat. 62°28′52.33″ N, long. 141°00′00.00″ W)</ENT>
                        </ROW>
                    </GPOTABLE>
                    <STARS/>
                </EXTRACT>
                <SIG>
                    <DATED>Issued in Washington, DC, on October 14, 2021.</DATED>
                    <NAME>Michael R. Beckles,</NAME>
                    <TITLE>Acting Manager, Rules and Regulations Group.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-22778 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 71</CFR>
                <DEPDOC>[Docket No. FAA-2021-0817; Airspace Docket No. 20-AAL-45]</DEPDOC>
                <RIN>RIN 2120-AA66</RIN>
                <SUBJECT>Proposed Establishment of United States Area Navigation (RNAV) Route T-308; Anvik, AK</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking (NPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This action proposes to establish United States Area Navigation (RNAV) route T-308 in the vicinity of Anvik, AK in support of a large and comprehensive T-route modernization project for the state of Alaska.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before December 6, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1(800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2021-0817; Airspace Docket No. 20-AAL-45 at the beginning of your 
                        <PRTPAGE P="58612"/>
                        comments. You may also submit comments through the internet at 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                    <P>
                        FAA Order JO 7400.11F, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at 
                        <E T="03">https://www.faa.gov/air_traffic/publications/.</E>
                    </P>
                    <P>
                        For further information, you can contact the Rules and Regulations Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC, 20591; telephone: (202) 267-8783. FAA Order JO 7400.11F is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order JO 7400.11F at NARA, email: 
                        <E T="03">fr.inspection@nara.gov</E>
                         or go to 
                        <E T="03">https://www.archives.gov/federal-register/cfr/ibr-locations.html.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Christopher McMullin, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would expand the availability of RNAV in Alaska and improve the efficient flow of air traffic within the National Airspace System (NAS) by lessening the dependency on ground based navigation.</P>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.</P>
                <P>
                    Communications should identify both docket numbers (FAA Docket No. FAA-2021-0817; Airspace Docket No. 20-AAL-45) and be submitted in triplicate to the Docket Management Facility (see 
                    <E T="02">ADDRESSES</E>
                     section for address and phone number). You may also submit comments through the internet at 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <P>Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2021-0817; Airspace Docket No. 20-AAL-45.” The postcard will be date/time stamped and returned to the commenter.</P>
                <P>All communications received on or before the specified comment closing date will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.</P>
                <HD SOURCE="HD1">Availability of NPRM</HD>
                <P>
                    An electronic copy of this document may be downloaded through the internet at 
                    <E T="03">https://www.regulations.gov.</E>
                     Recently published rulemaking documents can also be accessed through the FAA's web page at 
                    <E T="03">https://www.faa.gov/air_traffic/publications/airspace_amendments/.</E>
                </P>
                <P>
                    You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see 
                    <E T="02">ADDRESSES</E>
                     section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays. An informal docket may also be examined during normal business hours at the office of the Western Service Center, Operations Support Group, Federal Aviation Administration, 2200 South 216th St., Des Moines, WA 98198.
                </P>
                <HD SOURCE="HD1">Availability and Summary of Documents for Incorporation by Reference</HD>
                <P>
                    This document proposes to amend FAA Order JO 7400.11F, Airspace Designations and Reporting Points, dated August 10, 2021, and effective September 15, 2021. FAA Order JO 7400.11F is publicly available as listed in the 
                    <E T="02">ADDRESSES</E>
                     section of this document. FAA Order JO 7400.11F lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>In 2003, Congress enacted the Vision 100-Century of Aviation Reauthorization Act (Pub. L. 108-176), which established a joint planning and development office in the FAA to manage the work related to the Next Generation Air Transportation System (NextGen). Today, NextGen is an ongoing FAA-led modernization of the nation's air transportation system to make flying safer, more efficient, and more predictable.</P>
                <P>
                    In support of NextGen, this proposal is part of a larger and comprehensive T-route modernization project in the state of Alaska. The project mission statement states: “To modernize Alaska's Air Traffic Service route structure using satellite based navigation Development of new T-routes and optimization of existing T-routes will enhance safety, increase efficiency and access, and will provide en route continuity that is not subject to the restrictions associated with ground based airway navigation.” As part of this project, the FAA evaluated the existing Colored Airway structure for: (a) Direct replacement (
                    <E T="03">i.e.,</E>
                     overlay) with a T-route that offers a similar or lower Minimum En route Altitude (MEA) or Global Navigation Satellite System Minimum En route Altitude (GNSS MEA); (b) the replacement of the colored airway with a T-route in an optimized but similar geographic area, while retaining similar or lower MEA; or (c) removal with no route structure (T-route) restored in that area because the value was determined to be insignificant.
                </P>
                <P>The aviation industry/users have indicated a desire for the FAA to transition the Alaskan en route navigation structure away from dependency on Non-Directional Beacons (NDB), and move to develop and improve the RNAV route structure. The FAA proposes to establish RNAV route T-308 to provide an alternate routing for Alaskan VOR Federal airway V-510. V-510 utilizes Emmonak, AK, (ENM) VOR/DME, and ANVIK, AK, (ANV) NDB. ANV is on the scheduled decommission list, and will force the deletion of V-510 at that time.</P>
                <HD SOURCE="HD1">The Proposal</HD>
                <P>
                    The FAA is proposing an amendment to 14 CFR part 71 to establish RNAV route T-308 in the vicinity of Anvik, AK in support of a large and comprehensive T-route modernization project for the state of Alaska. The proposed route is described below.
                    <PRTPAGE P="58613"/>
                </P>
                <P>
                    <E T="03">T-308:</E>
                     The FAA proposes to establish T-308 from ENM to the WEREL, AK, waypoint, which would be a replacement for ANV. The route would mirror the current V-510.
                </P>
                <P>United States Area Navigation Routes are published in paragraph 6011 of FAA Order JO 7400.11F dated August 10, 2021 and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The RNAV route listed in this document would be published subsequently in FAA Order JO 7400.11F.</P>
                <P>FAA Order JO 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.</P>
                <HD SOURCE="HD1">Regulatory Notices and Analyses</HD>
                <P>The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.</P>
                <HD SOURCE="HD1">Environmental Review</HD>
                <P>This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 71</HD>
                    <P>Airspace, Incorporation by reference, Navigation (air).</P>
                </LSTSUB>
                <HD SOURCE="HD1">The Proposed Amendment</HD>
                <P>In consideration of the foregoing, the Federal Aviation Administration proposes to  amend 14 CFR part 71 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 71 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 71.1 </SECTNO>
                    <SUBJECT> [Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO 7400.11F, Airspace Designations and Reporting Points, dated August 10, 2021, and effective September 15, 2021, is amended as follows:</AMDPAR>
                <EXTRACT>
                    <HD SOURCE="HD2">Paragraph 6011 United States Area Navigation Routes.</HD>
                    <STARS/>
                    <GPOTABLE COLS="3" OPTS="L0,tp0,p0,7/8,g1,t1,i1" CDEF="xls80,xls50,xls180">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1"> </CHED>
                            <CHED H="1"> </CHED>
                        </BOXHD>
                        <ROW EXPSTB="02">
                            <ENT I="22">
                                <E T="04">T-308 Emmonak, AK to WEREL, AK [New]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">EMMONAK, AK (ENM)</ENT>
                            <ENT>VOR/DME</ENT>
                            <ENT>(Lat. 62°47′04.52″ N, long. 164°29′15.12″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">WEREL, AK</ENT>
                            <ENT>WP</ENT>
                            <ENT>(Lat. 62°38′29.25″ N, long. 160°11′07.20″ W)</ENT>
                        </ROW>
                    </GPOTABLE>
                    <STARS/>
                </EXTRACT>
                <SIG>
                    <DATED>Issued in Washington, DC, on October 12, 2021.</DATED>
                    <NAME>Michael R. Beckles,</NAME>
                    <TITLE>Acting Manager, Rules and Regulations Group.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-22547 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 71</CFR>
                <DEPDOC>[Docket No. FAA-2021-0853; Airspace Docket No. 19-AAL-44]</DEPDOC>
                <RIN>RIN 2120-AA66</RIN>
                <SUBJECT>Proposed Establishment of United States Area Navigation (RNAV) Route T-375; Bettles, AK</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking (NPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This action proposes to establish United States Area Navigation (RNAV) route T-375 in the vicinity of Bettles, AK in support of a large and comprehensive T-route modernization project for the state of Alaska.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before December 6, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1 (800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2021-0853; Airspace Docket No. 19-AAL-44 at the beginning of your comments. You may also submit comments through the internet at 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                    <P>
                        FAA Order JO 7400.11F, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at 
                        <E T="03">https://www.faa.gov/air_traffic/publications/.</E>
                         For further information, you can contact the Rules and Regulations Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783. FAA Order JO 7400.11F is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order JO 7400.11F at NARA, email: 
                        <E T="03">fr.inspection@nara.gov</E>
                         or go to 
                        <E T="03">https://www.archives.gov/federal-register/cfr/ibr-locations.html.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Christopher McMullin, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would expand the availability of RNAV in Alaska and improve the efficient flow of air traffic within the National Airspace System (NAS) by lessening the dependency on ground based navigation.</P>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>
                    Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments as they may desire. 
                    <PRTPAGE P="58614"/>
                    Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.
                </P>
                <P>
                    Communications should identify both docket numbers (FAA Docket No. FAA-2021-0853; Airspace Docket No. 19-AAL-44) and be submitted in triplicate to the Docket Management Facility (see 
                    <E T="02">ADDRESSES</E>
                     section for address and phone number). You may also submit comments through the internet at 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <P>Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2021-0853; Airspace Docket No. 19-AAL-44.” The postcard will be date/time stamped and returned to the commenter.</P>
                <P>All communications received on or before the specified comment closing date will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.</P>
                <HD SOURCE="HD1">Availability of NPRM</HD>
                <P>
                    An electronic copy of this document may be downloaded through the internet at 
                    <E T="03">https://www.regulations.gov.</E>
                     Recently published rulemaking documents can also be accessed through the FAA's web page at 
                    <E T="03">https://www.faa.gov/air_traffic/publications/airspace_amendments/.</E>
                </P>
                <P>
                    You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see 
                    <E T="02">ADDRESSES</E>
                     section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays. An informal docket may also be examined during normal business hours at the office of the Western Service Center, Operations Support Group, Federal Aviation Administration, 2200 South 216th St., Des Moines, WA 98198.
                </P>
                <HD SOURCE="HD1">Availability and Summary of Documents for Incorporation by Reference</HD>
                <P>
                    This document proposes to amend FAA Order JO 7400.11F, Airspace Designations and Reporting Points, dated August 10, 2021, and effective September 15, 2021. FAA Order JO 7400.11F is publicly available as listed in the 
                    <E T="02">ADDRESSES</E>
                     section of this document. FAA Order JO 7400.11F lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>In 2003, Congress enacted the Vision 100-Century of Aviation Reauthorization Act (Pub. L. 108-176), which established a joint planning and development office in the FAA to manage the work related to the Next Generation Air Transportation System (NextGen). Today, NextGen is an ongoing FAA-led modernization of the nation's air transportation system to make flying safer, more efficient, and more predictable.</P>
                <P>
                    In support of NextGen, this proposal is part of a larger and comprehensive T-route modernization project in the state of Alaska. The project mission statement states: “To modernize Alaska's Air Traffic Service route structure using satellite based navigation Development of new T-routes and optimization of existing T-routes will enhance safety, increase efficiency and access, and will provide en route continuity that is not subject to the restrictions associated with ground based airway navigation.” As part of this project, the FAA evaluated the existing Colored Airway structure for: (a) Direct replacement (
                    <E T="03">i.e.,</E>
                     overlay) with a T-route that offers a similar or lower Minimum En route Altitude (MEA) or Global Navigation Satellite System Minimum En route Altitude (GNSS MEA); (b) the replacement of the colored airway with a T-route in an optimized but similar geographic area, while retaining similar or lower MEA; or (c) removal with no route structure (T-route) restored in that area because the value was determined to be insignificant.
                </P>
                <P>The aviation industry/users have indicated a desire for the FAA to transition the Alaskan en route navigation structure away from dependency on Non-Directional Beacons (NDB), and move to develop and improve the RNAV route structure. The FAA proposes to establish RNAV route T-375 to provide an alternate routing for Colored Federal airways A-4, A-9, and A-3. The proposed route would provide a lower GNSS MEA than current routes, while also establishing an RNAV alternative (ZENSA waypoint (WP)) for the Anaktuvuk Pass, AK, (AKP) NDB.</P>
                <HD SOURCE="HD1">The Proposal</HD>
                <P>The FAA is proposing an amendment to 14 CFR part 71 to establish RNAV route T-375 in the vicinity of Bettles, AK in support of a large and comprehensive T-route modernization project for the state of Alaska. The proposed route is described below.</P>
                <P>
                    <E T="03">T-375:</E>
                     The FAA proposes to establish RNAV route T-375 from the Bettles, AK, (BTT) VHF Omnidirectional Range/distance measuring system (VOR/DME) to the DERIK, AK, WP, located northeast of AKP.
                </P>
                <P>United States Area Navigation Routes are published in paragraph 6011 of FAA Order JO 7400.11F dated August 10, 2021 and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The RNAV listed in this document would be published subsequently in FAA Order JO 7400.11F.</P>
                <P>FAA Order JO 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.</P>
                <HD SOURCE="HD1">Regulatory Notices and Analyses</HD>
                <P>The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.</P>
                <HD SOURCE="HD1">Environmental Review</HD>
                <P>This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 71</HD>
                    <P>Airspace, Incorporation by reference, Navigation (air).</P>
                </LSTSUB>
                <PRTPAGE P="58615"/>
                <HD SOURCE="HD1">The Proposed Amendment</HD>
                <P>In consideration of the foregoing, the Federal Aviation Administration proposes to  amend 14 CFR part 71 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 71 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 71.1</SECTNO>
                    <SUBJECT> [Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO 7400.11F, Airspace Designations and Reporting Points, dated August 10, 2021, and effective September 15, 2021, is amended as follows:</AMDPAR>
                <EXTRACT>
                    <HD SOURCE="HD2">Paragraph 6011 United States Area Navigation Routes.</HD>
                    <STARS/>
                    <GPOTABLE COLS="3" OPTS="L0,tp0,p0,7/8,g1,t1,i1" CDEF="xls80,xls50,xls180">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1"> </CHED>
                            <CHED H="1"> </CHED>
                        </BOXHD>
                        <ROW EXPSTB="02">
                            <ENT I="22">
                                <E T="04">T-375 Bettles, AK to DERIK, AK [New]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">BETTLES, AK (BTT) </ENT>
                            <ENT>VOR/DME </ENT>
                            <ENT>(Lat. 66°54′18.03″ N, long. 151°32′09.18″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">FEDEN, AK </ENT>
                            <ENT>WP </ENT>
                            <ENT>(Lat. 67°02′55.69″ N, long. 151°49′50.84″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">HEKDU, AK </ENT>
                            <ENT>WP </ENT>
                            <ENT>(Lat. 67°17′29.94″ N, long. 151°55′19.72″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">TOUTS, AK </ENT>
                            <ENT>WP </ENT>
                            <ENT>(Lat. 67°25′09.10″ N, long. 152°00′27.45″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">ZEBUR, AK </ENT>
                            <ENT>WP </ENT>
                            <ENT>(Lat. 67°32′54.42″ N, long. 152°06′57.25″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">RUTTY, AK </ENT>
                            <ENT>WP </ENT>
                            <ENT>(Lat. 67°48′23.58″ N, long. 152°23′44.42″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">FERKA, AK </ENT>
                            <ENT>WP </ENT>
                            <ENT>(Lat. 68°04′21.87″ N, long. 152°10′10.28″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">ZENSA, AK </ENT>
                            <ENT>WP </ENT>
                            <ENT>(Lat. 68°08′59.01″ N, long. 151°48′59.16″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">HAKSA, AK </ENT>
                            <ENT>WP </ENT>
                            <ENT>(Lat. 68°21′02.57″ N, long. 151°28′53.81″ W)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">DERIK, AK </ENT>
                            <ENT>WP </ENT>
                            <ENT>(Lat. 68°57′06.14″ N, long. 149°43′17.31″ W)</ENT>
                        </ROW>
                    </GPOTABLE>
                    <STARS/>
                </EXTRACT>
                <SIG>
                    <DATED>Issued in Washington, DC, on October 14, 2021.</DATED>
                    <NAME>Michael R. Beckles,</NAME>
                    <TITLE>Acting Manager, Rules and Regulations Group.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-22776 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>Bureau of Industry and Security</SUBAGY>
                <CFR>15 CFR Parts 740 and 774</CFR>
                <DEPDOC>[Docket No. 210910-0182]</DEPDOC>
                <RIN>RIN 0694-AI58</RIN>
                <SUBJECT>Clarifications of Availability and Expansion of Restrictions on Availability of License Exception Strategic Trade Authorization Under the Export Administration Regulations</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Industry and Security, Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In this rule, the Bureau of Industry and Security (BIS) proposes to amend the Export Administration Regulations (EAR) to clarify and expand restrictions on the availability of License Exception Strategic Trade Authorization (License Exception STA or STA) for the export, reexport and transfer (in-country) of certain items controlled under the EAR. Specifically, BIS proposes to clarify the “Special Conditions for STA” paragraph in certain Category 9 Export Control Classification Numbers (ECCNs) on the Commerce Control List to refer exporters to the limitations set forth in the EAR. Also, continuing its efforts to improve export controls and refine License Exception STA, BIS proposes to further restrict the availability of License Exception STA for certain technology controlled under ECCNs 2E003.f and 1E001. This rule also proposes related conforming amendments in License Exception STA and in affected ECCNs.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received by December 6, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments through either of the following:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                         The identification number for this rulemaking is BIS- 2020-0023. All filers using the portal should use the name of the person or entity submitting comments as the name of their files, in accordance with the instructions below. Persons or entities submitting business confidential information should clearly identify the business confidential portion at the time of submission, file a statement justifying nondisclosure and referring to the specific legal authority claimed, and provide a non-confidential version of the submission. For comments submitted electronically containing business confidential information, the file name of the business confidential version should begin with the characters “BC.” Any page containing business confidential information must be clearly marked “BUSINESS CONFIDENTIAL” on the top of that page. The corresponding non-confidential version of those comments must be clearly marked “PUBLIC.” The file name of the non-confidential version should begin with the character “P.” The “BC” and “P” should be followed by the name of the person or entity submitting the comments or rebuttal comments. Any submissions with file names that do not begin with a “BC” or “P” will be assumed to be public and will be made publicly available through 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                    <P>
                        • 
                        <E T="03">Address:</E>
                         By mail or delivery to Regulatory Policy Division, Bureau of Industry and Security, U.S. Department of Commerce, Room 2099B, 14th Street and Pennsylvania Avenue NW, Washington, DC 20230. Refer to RIN 0694-AI58. If you seek to submit business confidential information, you must use the portal. BIS does not accept confidential business information by mail or delivery.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Michael Rithmire, Director, Sensors and Aviation Division, Office of National Security and Technology Transfer Controls, Bureau of Industry and Security, by phone at (202) 482-6105 or by email at 
                        <E T="03">Michael.Rithmire@bis.doc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    In a final rule published on June 16, 2011 (76 FR 35276) (June 16 rule), BIS established License Exception Strategic Trade Authorization (License Exception STA or STA) in part 740 (License Exceptions) of the Export Administration Regulations (EAR), as part of the initial effort to reform and modernize U.S. export controls. License Exception STA is set forth in § 740.20 of the EAR and authorizes exports, reexports, and transfers (in-country) of certain specified items to STA-eligible destinations, including the release of certain software source code and technology, as well as certain “600 series” items. There are two groups of STA-eligible destinations: 37 destinations that are included in 
                    <PRTPAGE P="58616"/>
                    “Country Group A:5” and are eligible under § 740.20(c)(1), and eight destinations included in “Country Group A:6” and eligible under § 740.20(c)(2). These country group listings appear in Supplement No. 1 to Part 740 (Country Groups). The destinations in these two country groups pose low risk that those items will be used for a purpose that BIS license requirements are designed to prevent. The requirements and conditions for use of License Exception STA include the creation and exchange by the parties to the transaction of notifications and statements designed to provide assurance against diversion of such items to other destinations.
                </P>
                <P>Section 740.20(b) of the EAR sets forth various prohibitions and limitations on the use of License Exception STA, including in § 740.20(b)(2)(viii), which prohibits use of STA, regardless of destination, for certain Category 9 export control classification numbers (ECCNs). Certain software and technology controlled under ECCNs 9D001, 9D002, 9D004, 9E001, 9E002, and 9E003 are among the Category 9 items to which this prohibition applies. However, as a result of text adopted in the June 16 rule in response to certain public comments, the “Special Conditions for STA” paragraphs of these Category 9 ECCNs are not as comprehensive as § 740.20(b)(2)(viii), which potentially confuses exporters. More specifically, these paragraphs state that STA eligibility for certain software and technology controlled under the ECCNs is excluded to destinations in Country Group A:6, while the controlling text of § 740.20(b)(2)(viii) excludes STA eligibility for these items regardless of destination. In this rule, BIS proposes to clarify the “Special Conditions for STA” paragraphs included under ECCNs 9D001, 9D002, 9D004, 9E001, 9E002 and 9E003 in order to reduce the possibility of confusion. The clarified text, which does not change license requirements or restrictions, would direct exporters, reexporters, and in-country transferors to the Category 9 limitations on the use of STA set forth in § 740.20(b)(2)(viii), when determining STA availability for the export, reexport and in-country transfer of certain items controlled under those ECCNs.</P>
                <P>
                    The June 16 rule informed the public that BIS would undertake further review regarding whether technology controlled under ECCN 2E003.f related to the application of certain coatings is, in whole or in part, appropriate for exclusion from License Exception STA. 
                    <E T="03">See</E>
                     76 FR 35276, 35278 (6/16/2011). ECCN 2E003.f controls technology for the application of inorganic overlay coatings or inorganic surface modification coatings to non-electronic substrates by certain coating processes. The coating processes specified in this ECCN are critical to the performance of gas turbine engine hot section parts, but are also used for other manufacturing processes, such as optics. The operating environment of engine hot section parts and components is above the actual melting point of the base alloy used to cast these parts; however, the alloy does not melt due to three key technologies: Casting (controlled in ECCN 9E003), cooling (controlled in ECCNs 9E001 and 9E003), and coatings (controlled in ECCNs 2E003.f and 9E003). While hot section technologies (controlled for Significant Items (SI) reasons) require a license for export to destinations worldwide (except Canada) and are not eligible for export under license exceptions, coating technologies controlled in ECCN 2E003.f are not controlled for SI reasons and are currently eligible for export to destinations in Country Group A:5 under License Exception STA. Recognizing that the scope of 2E003.f coating technology includes technology with sensitive industrial applications, this proposed rule would expand restrictions on the use of License Exception STA for ECCN 2E003.f technology, when the technology is used for the application of inorganic overlay coatings on gas turbine engine combustors, or turbine blades, vanes or “tip shrouds” by adding a new restriction in paragraph (b)(2)(ix) of § 740.20.
                </P>
                <P>During this review of coating technology, inconsistencies were also identified in the eligibility of License Exceptions STA and Technology and Software Under Restriction (TSR) (see: § 740.6 of the EAR) for “development” and “production” technology in ECCN 1E001 that has applications in the “development” and “production” of hot section gas turbine parts and components as well as advanced military composite structures. The Special Conditions for STA paragraph in ECCN 1E001 currently prohibits the use of License Exception STA to ship or transmit “technology” for the “development” or “production” of equipment and materials specified by ECCNs 1A002, 1C001, 1C007.c or .d, 1C010.c or .d to any of the destinations listed in Country Group A:6. Some of the technology for which License Exception STA may not be used, however, is eligible for export under License Exception TSR not just to destinations in Country Group A:6, but to a broader universe of destinations in Country Group B.</P>
                <P>In addition, current STA eligibility with regard to Country Group A:6 destinations for 1E001 technology with applications in hot section gas turbine parts is inconsistent with  § 740.20(b)(2)(viii)'s prohibition on the use of STA with regard to all destinations for hot section technology in Category 9. Moreover, the exclusions from License Exceptions STA and TSR in ECCN 1E001 do not list ECCN 1E001 technology related to materials in Category 1 that are critical to the “development” or “production” of advanced composite aircraft structures—specifically, “development” or “production” technology for high temperature resins controlled under ECCNs 1C008 or 1C009 and fibers or fibers pre-impregnated with a resin (prepregs) controlled in ECCNs 1C007 or 1C010.</P>
                <P>This rule proposes to exclude License Exception STA eligibility to all destinations for technology described by ECCN 1E001 for the “development” or “production” of equipment and materials specified by ECCNs 1A002, 1C001, 1C007.c, 1C008.a.1, 1C009.b, and 1C010.b, .c or .d. This rule also proposes to correct the inconsistencies between License Exceptions STA and TSR and to exclude these same technologies from eligibility for License Exception TSR.</P>
                <P>BIS also proposes to make conforming amendments throughout License Exception STA § 740.20(b) and in affected ECCNs.</P>
                <P>BIS seeks public comments on the amendments to the EAR proposed in this rule.</P>
                <HD SOURCE="HD2">Export Control Reform Act of 2018</HD>
                <P>On August 13, 2018, the President signed into law the John S. McCain National Defense Authorization Act for Fiscal Year 2019, which included the Export Control Reform Act of 2018 (ECRA), 50 U.S.C. 4801-4852. ECRA provides the legal basis for BIS's principal authorities and serves as the authority under which BIS issues this rule.</P>
                <HD SOURCE="HD1">Rulemaking Requirements</HD>
                <P>
                    1. Executive Orders 13563 and 12866 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, and other advantages; distributive impacts; and equity). Executive Order 13563 emphasizes the 
                    <PRTPAGE P="58617"/>
                    importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This proposed rule has been designated a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866.
                </P>
                <P>2. This rule does not contain policies with federalism implications as that term is defined in Executive Order 13132.</P>
                <P>
                    3. Notwithstanding any other provision of law, no person is required to respond to, nor may a person be made subject to a penalty for failure to comply, with a collection of information subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This regulation involves collections previously approved by OMB under control number 0694-0088, Simplified Network Application Processing System, which includes, among other things, license applications and carries a burden estimate of 42.5 minutes for a manual or electronic submission.
                </P>
                <P>BIS expects the total burden hours associated with this collection to increase if this proposed rule is adopted in final form, because the proposal limits availability of License Exception STA. Transactions no longer eligible for this license exception will require licenses. Trying to estimate the number of licenses is difficult because exports of intangible technology are not reported as Electronic Export Information, limiting the broad availability of transaction data. This proposal with request for comments should help get input from the public to inform this issue. The request for comments, including supporting relevant data, on this rule is intended to inform further review of the proposed amendments, if they were to be issued in final form.</P>
                <P>
                    Any comments regarding the collection of information associated with this rule, including suggestions for reducing the burden, may be sent to Jasmeet K. Seehra, OMB, online at 
                    <E T="03">https://www.reginfo.gov/public/do/PRAMain.</E>
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects</HD>
                    <CFR>15 CFR Part 740</CFR>
                    <P>Administrative practice and procedure, Exports, Reporting and recordkeeping requirements.</P>
                    <CFR>15 CFR Part 774</CFR>
                    <P>Exports, Reporting and recordkeeping.</P>
                </LSTSUB>
                <P>For the reasons set forth in the preamble, 15 CFR chapter VII, subchapter C, is proposed to be amended as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 740—[AMENDED]</HD>
                </PART>
                <AMDPAR>1. The authority citation for 15 CFR part 740 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P>
                        50 U.S.C. 4801-4852; 50 U.S.C. 4601 
                        <E T="03">et seq.;</E>
                         50 U.S.C. 1701 
                        <E T="03">et seq.;</E>
                         22 U.S.C. 7201 
                        <E T="03">et seq.;</E>
                         E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783.
                    </P>
                </AUTH>
                <AMDPAR>2. Revise paragraph (b) of § 740.20 to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>§ 740.20</SECTNO>
                    <SUBJECT> License Exception Strategic Trade Authorization (STA).</SUBJECT>
                    <STARS/>
                    <P>
                        (b) 
                        <E T="03">Requirements and limitations</E>
                        —(1) 
                        <E T="03">Requirements for using License Exception STA.</E>
                         (i) All of the reasons for control that impose a license requirement under part 742 of the EAR on the export, reexport, or in country transfer must be addressed in at least one authorizing paragraph in paragraph (c) of this section.
                    </P>
                    <P>(ii) The party using License Exception STA must comply with all of the requirements in paragraph (d) of this section.</P>
                    <P>
                        (2) 
                        <E T="03">Limitations on use of License Exception STA.</E>
                         The prohibitions and limits of this paragraph (b)(2) apply notwithstanding the authorizations in paragraph (c) of this section.
                    </P>
                    <P>(i) License Exception STA may not be used in lieu of any license requirement imposed by part 744 or 746 of the EAR.</P>
                    <P>(ii) License Exception STA may not be used for:</P>
                    <P>(A) Any item controlled in ECCNs 0A501.a, .b, .c, .d, or .e; 0A503; 0A981; 0A982; 0A983; 0E504; 0E982; or</P>
                    <P>(B) Shotguns with barrel length less than 18 inches controlled in 0A502.</P>
                    <P>(iii) License Exception STA may not be used for any item that is controlled for reason of encryption items (EI), short supply (SS), surreptitious listening (SL), missile technology (MT), or chemical weapons (CW).</P>
                    <P>(iv) License Exception STA may not be used for any item identified on the CCL as being subject to the exclusive export control jurisdiction of another agency, such as the Department of State, the Department of Energy, or the Nuclear Regulatory Commission.</P>
                    <P>(v) License Exception STA may not be used for:</P>
                    <P>(A) Any item controlled by ECCN 1C351.a, .b, .c, .d.11, .d.12 or .e; ECCNs 1C353; 1C354; or ECCN 1E351; or</P>
                    <P>(B) ECCN 1E001 “technology” for the “development” or “production” of items specified in ECCNs 1A002; 1C001; 1C007.c or .d; 1C008.a.1; 1C009.b; 1C010.b, .c or .d; 1C351.a, .b, .c, .d.11, .d.12 or .e; 1C353; or 1C354.</P>
                    <P>(vi) Toxins controlled by ECCN 1C351.d.1 through 1C351.d.10 and 1C351.d.13 through 1C351.d.19 are authorized under License Exception STA to destinations indicated in Country Group A:5 (See Supplement No. 1 to this part), subject to the following limits. For purposes of this paragraph (b)(2)(vi), all such toxins that are sent from one exporter, reexporter, or transferor to a single end-user, on the same day, constitute one shipment.</P>
                    <P>(A) The maximum amount of any one toxin in any one shipment may not exceed 100 milligrams.</P>
                    <P>(B) No exporter, reexporter, or transferor may send more than six shipments of any one toxin to any one end user in a single calendar year.</P>
                    <P>(vii) Commerce Control List Category 7 limitation on use of License Exception STA. License Exception STA may not be used for ECCN 7E004 “technology,” except for “technology” controlled under ECCN 7E004.a.7.</P>
                    <P>(viii) Commerce Control List Category 9 limitations on use of License Exception STA.</P>
                    <P>(A) License Exception STA may not be used for ECCN 9D001 or 9D002 “software” that is specially designed or modified for the “development” or “production” of:</P>
                    <P>
                        (
                        <E T="03">1</E>
                        ) Components of engines controlled by ECCN 9A001 if such components incorporate any of the “technologies” controlled by ECCN 9E003.a.1, 9E003.a.2, 9E003.a.3, 9E003.a.4, 9E003.a.5, 9E003.c, 9E003.i (other than technology for fan or power turbines), 9E003.h; or
                    </P>
                    <P>
                        (
                        <E T="03">2</E>
                        ) Equipment controlled by ECCN 9B001.
                    </P>
                    <P>(B) License Exception STA may not be used for ECCN 9D001 “software” that is specially designed or modified for the “development” of “technology” controlled by ECCN 9E003.a.1, 9E003.a.2, 9E003.a.3, 9E003.a.4, 9E003.a.5, 9E003.c, 9E003.i (other than technology for fan or power turbines) or ECCN 9E003.h. License Exception STA may not be used for ECCN 9D001 “software” that is specially designed or modified for the “development” of “technology” covered by 9E003.a.8 to any of the destinations listed in Country Group A:6.</P>
                    <P>
                        (C) License Exception STA may not be used for ECCN 9D004.f or 9D004.g “software” to Country Group A:5 or A:6, and may not be used for ECCN 9D004.a or 9D004.c “software” to any of the destinations listed in Country Group A:6 (See Supplement No. 1 to part 740 of the EAR).
                        <PRTPAGE P="58618"/>
                    </P>
                    <P>(D) License Exception STA may not be used for 9E001 “technology” to any of the destinations listed in Country Group A:6. In addition, License Exception STA may not be used to Country Group A:5 or A:6 for 9E001 “technology” according to the General Technology Note for the “development” of ECCN 9A001.b engines or components of engines controlled by ECCN 9A001.b if such components incorporate:</P>
                    <P>
                        (
                        <E T="03">1</E>
                        ) Any of the “technologies” controlled by ECCN 9E003.a.1, 9E003.a.2, 9E003.a.3, 9E003.a.4, 9E003.a.5, 9E003.c, 9E003.i (other than technology for fan or power turbines) or 9E003.h; or
                    </P>
                    <P>
                        (
                        <E T="03">2</E>
                        ) Any of the ECCN 9D001 or 9D002 software in paragraph (b)(2)(viii)(A) or (B) of this section.
                    </P>
                    <P>(E) License Exception STA may not be used for 9E002 “technology” to any of the destinations in Country Group A:6. In addition, License Exception STA may not be used for Country Group A:5 or A:6 for 9E002 “technology” according to the General Technology Note for the “production” of components of engines controlled by 9A001.b if such components incorporate any of the “technologies” controlled by 9E003.a.1, 9E003.a.2, 9E003.a.3, 9E003.a.4, 9E003.a.5, 9E003.c, 9E003.i (other than technology for fan or power turbines), or 9E003.h.</P>
                    <P>(F) License Exception STA may not be used for “technology” covered by 9E003.a.1, 9E003.a.2, 9E003.a.3, 9E003.a.4, 9E003.a.5, 9E003.c, 9E003.i (other than technology for fan or power turbines), or 9E003.h. License Exception STA may not be used for “technology” covered by 9E003.a.8 to any of the destinations listed in Country Group A:6.</P>
                    <P>(ix) License Exception STA may not be used for “technology” according to the General Technology Note for 2E003.f when used for the application of inorganic overlay coatings on gas turbine engine combustors, or turbine blades, vanes or “tip shrouds.”</P>
                    <P>(x) License Exception STA may not be used for items controlled by ECCNs 6A002; 6D002 (software “specially designed” for the “use” of commodities controlled under 6A002.b); 6D003.c; 6D991 (software “specially designed” for the “development,” “production,” or “use” of commodities controlled under 6A002 or 6A003); 6E001 (“technology” for the “development” of commodities controlled under ECCNs 6A002 or 6A003); or 6E002 “technology” (for the “production” of commodities controlled under ECCNs 6A002 or 6A003).</P>
                    <P>(xi) License Exception STA may not be used for any commodity controlled by ECCN 3A001.b.2 or .b.3 (except those that are being exported or reexported for use in civil telecommunications applications), or any “technology” controlled by 3E001 for the “production” or “development” of commodities controlled by 3A001.b.2 or .b.3.</P>
                    <P>
                        (3) 
                        <E T="03">Limitations on the use of STA that are specific to “600 series” items.</E>
                         (i) License Exception STA may not be used for any “600 series” items identified in the relevant ECCN as not being eligible for STA.
                    </P>
                    <P>(ii) License Exception STA may be used to export, reexport, and transfer (in-country) “600 series” items to persons in Country Group A:5, whether non-governmental or governmental, and, for natural persons, if they are nationals of a country listed in Country Group A:5 (See Supplement No. 1 to part 740 of the EAR) or the United States, and if:</P>
                    <P>
                        (A) The 
                        <E T="03">ultimate</E>
                         end user for such items is the armed forces, police, paramilitary, law enforcement, customs, correctional, fire, or a search and rescue agency of a government of one of the countries listed in Country Group A:5, or the United States Government;
                    </P>
                    <P>(B) For the “development,” “production,” operation, installation, maintenance, repair, overhaul, or refurbishing of an item in one of the countries listed in Country Group A:5 or the United States that will be for one, or more, of the following purposes:</P>
                    <P>
                        (
                        <E T="03">1</E>
                        ) Ultimately to be used by any such government agencies in one of the countries listed in Country Group A:5 or the United States Government; or
                    </P>
                    <P>
                        (
                        <E T="03">2</E>
                        ) Sent to a person in the United States and not for subsequent export under § 740.9(b)(1) (License Exception TMP for items moving in transit through the United States); or
                    </P>
                    <P>(C) The United States Government has otherwise authorized the ultimate end use, the license or other authorization is in effect, and the consignee verifies in writing that such authorization exists and has provided the license or other approval identifier to the exporter, reexporter or transferor (as applicable).</P>
                    <P>(iii) License Exception STA may not be used to export, reexport, or transfer (in-country) end items described in ECCN 0A606.a, ECCN 8A609.a, ECCN 8A620.a or .b, or ECCN 9A610.a until after BIS has approved their export under STA under the procedures set out in paragraph (g) of this section.</P>
                    <P>(iv) License Exception STA may not be used to export, reexport, or transfer (in-country) “600 series” items if they are “600 Series Major Defense Equipment” and the value of such items in the contract requiring their export exceeds $25,000,000.</P>
                    <P>
                        <E T="04">Note 1 to paragraphs (b)(2) and (3):</E>
                         Any export, reexport, or transfer (in-country) originally authorized under License Exception STA must stay within the scope of the original authorization. For example, for “600 series” items authorized under License Exception STA, such items must be provided to an eligible ultimate end user, such as a Country Group A:5 military, to stay in compliance with the original authorization. This requirement for the “600 series” is referred to as `completing the chain,' meaning regardless of how many times the “600 series” item is transferred (in-country) or whether the “600 series” item is incorporated into higher level assemblies or other items, the “600 series” item must ultimately be provided to an eligible ultimate end user, or be otherwise authorized under the EAR. This applies regardless of whether the “600 series” item has been incorporated into a foreign-made item that may no longer be “subject to the EAR.” Because the other items eligible for authorization under License Exception STA (9x515 and other non-600 series ECCNs) do not include the “600 series” requirements specific to the ultimate end user, this `completing the chain' concept does not apply to 9x515 and other non-600 series ECCNs authorized under License Exception STA. However, the original export, reexport, or transfer (in-country) made under License Exception STA for 9x515 and other non-600 series ECCNs still must comply with the original authorization—meaning the terms and conditions of License Exception STA.
                    </P>
                    <STARS/>
                </SECTION>
                <PART>
                    <HD SOURCE="HED">PART 774—[AMENDED]</HD>
                </PART>
                <AMDPAR>3. The authority citation for 15 CFR part 774 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>
                         50 U.S.C. 4801-4852; 50 U.S.C. 4601 
                        <E T="03">et seq.;</E>
                         50 U.S.C. 1701 
                        <E T="03">et seq.;</E>
                         10 U.S.C. 8720; 10 U.S.C. 8730(e); 22 U.S.C. 287c, 22 U.S.C. 3201 
                        <E T="03">et seq.;</E>
                         22 U.S.C. 6004; 42 U.S.C. 2139a; 15 U.S.C. 1824; 50 U.S.C. 4305; 22 U.S.C. 7201 
                        <E T="03">et seq.;</E>
                         22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783.
                    </P>
                </AUTH>
                <AMDPAR>4. In Supplement No. 1 to part 774, Category 1, Export Control Classification Number (ECCN) 1E001 is revised to read as follows:</AMDPAR>
                <HD SOURCE="HD1">SUPPLEMENT NO. 1 TO PART 774—THE COMMERCE CONTROL LIST</HD>
                <EXTRACT>
                    <STARS/>
                    <FP SOURCE="FP-2">
                        <E T="04">
                            1E001 “Technology” according to the General Technology Note for the 
                            <PRTPAGE P="58619"/>
                            “development” or “production” of items controlled by 1A002, 1A003, 1A004, 1A005, 1A006.b, 1A007, 1A008 1A101, 1A231, 1B (except 1B608, 1B613 or 1B999), or 1C (except 1C355, 1C608, 1C980 to 1C984, 1C988, 1C990, 1C991, 1C995 to 1C999).
                        </E>
                    </FP>
                    <HD SOURCE="HD1">License Requirements</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">Reason for Control:</E>
                         NS, MT, NP, CB, RS, AT
                    </FP>
                    <GPOTABLE COLS="2" OPTS="L0,tp0,i1" CDEF="s10,r10">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1">
                                <E T="03">Control(s)</E>
                            </CHED>
                            <CHED H="1">
                                <E T="03">Country chart</E>
                                <LI>
                                    <E T="03">(See Supp. No. 1 to part 738)</E>
                                </LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">NS applies to “technology” for items controlled by 1A002, 1A003, 1A005, 1A006.b, 1A007, 1B001 to 1B003, 1C001 to 1C011</ENT>
                            <ENT>NS Column 1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">NS applies to “technology” for items controlled by 1A004</ENT>
                            <ENT>NS Column 2.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">MT applies to “technology” for items controlled by 1A101, 1B001, 1B101, 1B102, 1B115 to 1B119, 1C001, 1C007, 1C011, 1C101, 1C102, 1C107, 1C111, 1C116, 1C117, or 1C118 for MT reasons</ENT>
                            <ENT>MT Column 1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">NP applies to “technology” for items controlled by 1A002, 1A007, 1A231, 1B001, 1B101, 1B201, 1B225, 1B226, 1B228 to 1B234, 1C002, 1C010, 1C111, 1C116, 1C202, 1C210, 1C216, 1C225 to 1C237, or 1C239 to 1C241 for NP reasons</ENT>
                            <ENT>NP Column 1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CB applies to “technology” for items controlled by 1C351, 1C353, or 1C354</ENT>
                            <ENT>CB Column 1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CB applies to “technology” for materials controlled by 1C350 and for chemical detection systems and dedicated detectors therefor, in 1A004.c, that also have the technical characteristics described in 2B351.a</ENT>
                            <ENT>CB Column 2.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">RS applies to technology for equipment controlled in 1A004.d</ENT>
                            <ENT>RS Column 2.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">AT applies to entire entry</ENT>
                            <ENT>AT Column 1.</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD1">Reporting Requirements</HD>
                    <P>See § 743.1 of the EAR for reporting requirements for exports under License Exceptions, and Validated End-User authorizations.</P>
                    <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">TSR:</E>
                         Yes, except for the following:
                    </FP>
                    <P>(1) Items controlled for MT reasons; or</P>
                    <P>(2) Exports and reexports of “technology” for the “development” or production” of the following:</P>
                    <P>(a) Items controlled by 1A002, 1C001, 1C007.c, 1C008.a.1, 1C009.b, 1C010.b, c, or d</P>
                    <P>(b) [Reserved]</P>
                    <HD SOURCE="HD1">Special Conditions for STA</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">STA:</E>
                         See § 740.20(b)(2)(v) of License Exception STA for limitations on availability of STA for items in this entry.
                    </FP>
                    <HD SOURCE="HD1">List of Items Controlled</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">Related Controls</E>
                         (1) Also see ECCNs 1E101, 1E201, and 1E202. (2) See ECCN 1E608 for “technology” for items classified under ECCN 1B608 or 1C608 (note that ECCN 1E001 controls “development” and “production” “technology” for chlorine trifluoride controlled by ECCN 1C111.a.3.f—see ECCN 1E101 for controls on “use” “technology” for chlorine trifluoride). (3) See ECCN 1E002.g for control libraries (parametric technical databases) “specially designed” or modified to enable equipment to perform the functions of equipment controlled under ECCN 1A004.c (Nuclear, biological and chemical (NBC) detection systems) or ECCN 1A004.d (Equipment for detecting or identifying explosives residues). (4) “Technology” for lithium isotope separation (see related ECCN 1B233) and “technology” for items described in ECCN 1C012 are subject to the export licensing authority of the Department of Energy (see 10 CFR part 810). (5) “Technology” for items described in ECCN 1A102 is “subject to the ITAR” (see 22 CFR parts 120 through 130).
                    </FP>
                    <FP SOURCE="FP-1">
                        <E T="03">Related Definitions:</E>
                         N/A
                    </FP>
                    <FP SOURCE="FP-1">
                        <E T="03">Items:</E>
                    </FP>
                    <P>The list of items controlled is contained in the ECCN heading.</P>
                </EXTRACT>
                <AMDPAR>5. In Supplement No. 1 to part 774, Category 2, ECCN 2E003 is revised to read as follows:</AMDPAR>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        <E T="04">2E003 Other “technology”, as follows (see List of Items Controlled).</E>
                    </FP>
                    <HD SOURCE="HD1">License Requirements</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">Reason for Control:</E>
                         NS, AT
                    </FP>
                    <GPOTABLE COLS="2" OPTS="L0,tp0,i1" CDEF="s10,r10">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1">
                                <E T="03">Control(s)</E>
                            </CHED>
                            <CHED H="1">
                                <E T="03">Country chart</E>
                                <LI>
                                    <E T="03">(See Supp. No. 1 to part 738)</E>
                                </LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">NS applies to entire entry</ENT>
                            <ENT>NS Column 1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">AT applies to entire entry</ENT>
                            <ENT>AT Column 1.</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">TSR:</E>
                         Yes, except 2E003.b, .e and .f
                    </FP>
                    <HD SOURCE="HD1">Special Conditions for STA</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">STA:</E>
                         See § 740.20(b)(2)(ix) of License Exception STA for limitations on availability of STA for items in this entry.
                    </FP>
                    <HD SOURCE="HD1">List of Items Controlled</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">Related Controls:</E>
                         See 
                        <E T="03">2E001, 2E002,</E>
                         and 
                        <E T="03">2E101</E>
                         for “development” and “use” technology for equipment that are designed or modified for densification of carbon-carbon composites, structural composite rocket nozzles and reentry vehicle nose tips.
                    </FP>
                    <FP SOURCE="FP-1">
                        <E T="03">Related Definitions:</E>
                         N/A
                    </FP>
                    <FP SOURCE="FP-1">
                        <E T="03">Items:</E>
                    </FP>
                    <P>a. [Reserved]</P>
                    <P>b. “Technology” for metal-working manufacturing processes, as follows:</P>
                    <P>b.1. “Technology” for the design of tools, dies or fixtures “specially designed” for any of the following processes:</P>
                    <P>b.1.a. “Superplastic forming”;</P>
                    <P>
                        b.1.b. “Diffusion bonding”; 
                        <E T="03">or</E>
                    </P>
                    <P>b.1.c. “Direct-acting hydraulic pressing”;</P>
                    <P>b.2. Technical data consisting of process methods or parameters as listed below used to control:</P>
                    <P>b.2.a. “Superplastic forming” of aluminum alloys, titanium alloys or “superalloys”:</P>
                    <P>b.2.a.1. Surface preparation;</P>
                    <P>b.2.a.2. Strain rate;</P>
                    <P>b.2.a.3. Temperature;</P>
                    <P>b.2.a.4. Pressure;</P>
                    <P>b.2.b. “Diffusion bonding” of “superalloys” or titanium alloys:</P>
                    <P>b.2.b.1. Surface preparation;</P>
                    <P>b.2.b.2. Temperature;</P>
                    <P>b.2.b.3. Pressure;</P>
                    <P>b.2.c. ‘Direct-acting hydraulic pressing’ of aluminum alloys or titanium alloys:</P>
                    <P>b.2.c.1. Pressure;</P>
                    <P>b.2.c.2. Cycle time;</P>
                    <P>b.2.d. ‘Hot isostatic densification’ of titanium alloys, aluminum alloys or “superalloys”:</P>
                    <P>b.2.d.1. Temperature;</P>
                    <P>b.2.d.2. Pressure;</P>
                    <P>b.2.d.3. Cycle time;</P>
                    <P>
                        <E T="04">Technical Notes:</E>
                          
                        <E T="03">1. ‘Direct-acting hydraulic pressing’ is a deformation process which uses a fluid-filled flexible bladder in direct contact with the workpiece.</E>
                    </P>
                    <P>
                        <E T="03">2. ‘Hot isostatic densification’ is a process of pressurizing a casting at temperatures exceeding 375 K (102 °C) in a closed cavity through various media (gas, liquid, solid particles, etc.) to create equal force in all directions to reduce or eliminate internal voids in the casting.</E>
                    </P>
                    <P>c. “Technology” for the “development” or “production” of hydraulic stretch-forming machines and dies therefor, for the manufacture of airframe structures;</P>
                    <P>d. [Reserved]</P>
                    <P>
                        e. “Technology” for the “development” of integration “software” for incorporation of 
                        <PRTPAGE P="58620"/>
                        expert systems for advanced decision support of shop floor operations into “numerical control” units;
                    </P>
                    <P>f. “Technology” for the application of inorganic overlay coatings or inorganic surface modification coatings (specified in column 3 of the following table) to non-electronic substrates (specified in column 2 of the following table), by processes specified in column 1 of the following table and defined in the Technical Note.</P>
                    <P>
                        <E T="04">N.B.:</E>
                          
                        <E T="03">This table should be read to control the technology of a particular `Coating Process' only when the resultant coating in column 3 is in a paragraph directly across from the relevant `Substrate' under column 2. For example, Chemical Vapor Deposition (CVD) `coating process' control the “technology” for a particular application of `silicides' to `Carbon-carbon, Ceramic and Metal “matrix” “composites” substrates, but are not controlled for the application of `silicides' to `Cemented tungsten carbide (16), Silicon carbide (18)' substrates. In the second case, the resultant coating is not listed in the paragraph under column 3 directly across from the paragraph under column 2 listing `Cemented tungsten carbide (16), Silicon carbide (18)'.</E>
                    </P>
                    <GPOTABLE COLS="3" OPTS="L2,nj,i1" CDEF="s50,r50,r100">
                        <TTITLE>
                            Category 
                            <E T="01">2E</E>
                            —Materials Processing Table; Deposition Techniques
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">
                                1. Coating process (1) 
                                <SU>1</SU>
                            </CHED>
                            <CHED H="1">2. Substrate</CHED>
                            <CHED H="1">3. Resultant coating</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">A. Chemical Vapor Deposition (CVD)</ENT>
                            <ENT>“Superalloys”</ENT>
                            <ENT>Aluminides for internal passages.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Ceramics (19) and Low-expansion glasses (14)</ENT>
                            <ENT>Silicides, Carbides, Dielectric layers (15), Diamond, Diamond-like carbon (17).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Carbon-carbon, Ceramic, and Metal “matrix” “composites“</ENT>
                            <ENT>Silicides, Carbides, Refractory metals, Mixtures thereof (4), Dielectric layers (15), Aluminides, Alloyed aluminides (2), Boron nitride.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Cemented tungsten, carbide (16), Silicon carbide (18)</ENT>
                            <ENT>Carbides, Tungsten, Mixtures thereof (4), Dielectric layers (15).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Molybdenum and Molybdenum alloys</ENT>
                            <ENT>Dielectric layers (15).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Beryllium and Beryllium alloys</ENT>
                            <ENT>Dielectric layers (15), Diamond, Diamond-like carbon (17).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Sensor window materials (9)</ENT>
                            <ENT>Dielectric layers (15), Diamond, Diamond-like carbon (17).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">B. Thermal-Evaporation, Physical Vapor</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">1. Physical Vapor Deposition (PVD): Deposition (TE-PVD) Electron-Beam, (EB-PVD)</ENT>
                            <ENT>“Superalloys”</ENT>
                            <ENT>Alloyed silicides, Alloyed aluminides (2), MCrAlX (5), Modified zirconia (12), Silicides, Aluminides, Mixtures thereof (4).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Ceramics (19) and Low-expansion glasses (14)</ENT>
                            <ENT>Dielectric layers (15).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Corrosion resistant steel (7)</ENT>
                            <ENT>MCrAlX (5), Modified zirconia (12), Mixtures thereof (4).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Carbon-carbon, Ceramic and Metal “matrix” “composites”</ENT>
                            <ENT>Silicides, Carbides, Refractory metals, Mixtures thereof (4), Dielectric layers (15), Boron nitride.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Cemented tungsten carbide (16), Silicon carbide (18)</ENT>
                            <ENT>Carbides, Tungsten, Mixtures thereof (4), Dielectric layers (15).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Molybdenum and Molybdenum alloys</ENT>
                            <ENT>Dielectric layers (15).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Beryllium and Beryllium alloys</ENT>
                            <ENT>Dielectric layers (15), Borides, Beryllium.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Sensor window materials (9)</ENT>
                            <ENT>Dielectric layers (15).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Titanium alloys (13)</ENT>
                            <ENT>Borides, Nitrides.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">2. Ion assisted resistive heating Physical Vapor Deposition (PVD) (Ion Plating)</ENT>
                            <ENT>Ceramics (19) and Low-expansion glasses (14)</ENT>
                            <ENT>Dielectric layers (15), Diamond-like carbon (17).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Carbon-carbon, Ceramic and Metal “matrix” “composites”</ENT>
                            <ENT>Dielectric layers (15).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Cemented tungsten carbide (16), Silicon carbide</ENT>
                            <ENT>Dielectric layers (15).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Molybdenum and Molybdenum alloys</ENT>
                            <ENT>Dielectric layers (15).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Beryllium and Beryllium alloys</ENT>
                            <ENT>Dielectric layers (15).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Sensor window materials (9)</ENT>
                            <ENT>Dielectric Layers (15), Diamond-like carbon (17).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">3. Physical Vapor Deposition (PVD): “Laser” Vaporization</ENT>
                            <ENT>Ceramics (19) and Low-expansion glasses (14)</ENT>
                            <ENT>Silicides, Dielectric layers (15), Diamond-like carbon (17).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Carbon-carbon, Ceramic and Metal “matrix” “composites”</ENT>
                            <ENT>Dielectric layers (15).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Cemented tungsten carbide (16), Silicon carbide</ENT>
                            <ENT>Dielectric Layers (15).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Molybdenum and Molybdenum alloys</ENT>
                            <ENT>Dielectric layers (15).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Beryllium and Beryllium alloys</ENT>
                            <ENT>Dielectric layers (15).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Sensor window materials (9)</ENT>
                            <ENT>Dielectric layers (15), Diamond-like carbon.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">4. Physical Vapor Deposition (PVD): Cathodic Arc Discharge</ENT>
                            <ENT>“Superalloys”</ENT>
                            <ENT>Alloyed silicides, Alloyed Aluminides (2), MCrA1X (5).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Polymers (11) and Organic “matrix” “composites”</ENT>
                            <ENT>Borides, Carbides, Nitrides, Diamond-like carbon (17).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">C. Pack cementation (see A above for out-of-pack cementation) (10)</ENT>
                            <ENT>Carbon-carbon, Ceramic and Metal “matrix” “composites”</ENT>
                            <ENT>Silicides, Carbides, Mixtures thereof (4).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Titanium alloys (13)</ENT>
                            <ENT>Silicides, Aluminides, Alloyed aluminides (2).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Refractory metals and alloys (8)</ENT>
                            <ENT>Silicides, Oxides.</ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="58621"/>
                            <ENT I="01">D. Plasma spraying</ENT>
                            <ENT>“Superalloys”</ENT>
                            <ENT>MCrAlX (5), Modified zirconia (12), Mixtures thereof (4), Abradable Nickel-Graphite, Abradable materials containing, Ni-Cr-Al Abradable Al-Si-Polyester Alloyed aluminides (2).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Aluminum alloys (6)</ENT>
                            <ENT>MCrAlX (5), Modified zirconia (12), Silicides, Mixtures thereof (4).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Refractory metals and alloys (8), Carbides, Corrosion resistant steel (7)</ENT>
                            <ENT>Aluminides, Silicides, MCrAlX (5), Modified zirconia (12), Mixtures thereof (4).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Titanium alloys (13)</ENT>
                            <ENT>Carbides, Aluminides, Silicides, Alloyed aluminides (2).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Abradable Nickel Graphite</ENT>
                            <ENT>Abradable materials containing, Ni-Cr-Al, Abradable Al-Si-Polyester.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">E. Slurry Deposition</ENT>
                            <ENT>Refractory metals and alloys (8)</ENT>
                            <ENT>Fused silicides, Fused aluminides, except for resistance heating elements.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Carbon-carbon, Ceramic and Metal “matrix” “composites”</ENT>
                            <ENT>Silicides, Carbides, Mixtures thereof (4).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">F. Sputter Deposition</ENT>
                            <ENT>“Superalloys”</ENT>
                            <ENT>Alloyed silicides, Alloyed aluminides (2), Noble metal modified aluminides (3), MCrAlX (5), Modified zirconia (12), Platinum, Mixtures thereof (4).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Ceramics and Low-expansion glasses (14)</ENT>
                            <ENT>Silicides, Platinum, Mixtures thereof (4), Dielectric layers (15), Diamond-like carbon (17).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Titanium alloys (13)</ENT>
                            <ENT>Borides, Nitrides, Oxides, Silicides, Aluminides, Alloyed aluminides (2), Carbides.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Carbon-carbon, Ceramic and Metal “matrix” “Composites”</ENT>
                            <ENT>Silicides, Carbides, Refractory metals, Mixtures thereof (4), Dielectric layers (15), Boron nitride.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Cemented tungsten carbide (16), Silicon carbide (18)</ENT>
                            <ENT>Carbides, Tungsten, Mixtures thereof (4), Dielectric layers (15), Boron nitride.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Molybdenum and Molybdenum alloys</ENT>
                            <ENT>Dielectric layers (15).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Beryllium and Beryllium alloys</ENT>
                            <ENT>Borides, Dielectric layers (15), Beryllium.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Sensor window materials (9)</ENT>
                            <ENT>Dielectric layers (15), Diamond-like carbon (17).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Refractory metals and alloys (8)</ENT>
                            <ENT>Aluminides, Silicides, Oxides, Carbides.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">G. Ion Implantation</ENT>
                            <ENT>High temperature bearing steels</ENT>
                            <ENT>Additions of Chromium, Tantalum, or Niobium (Columbium).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Titanium alloys (13)</ENT>
                            <ENT>Borides, Nitrides.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Beryllium and Beryllium alloys</ENT>
                            <ENT>Borides.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Cemented tungsten carbide (16)</ENT>
                            <ENT>Carbides, Nitrides.</ENT>
                        </ROW>
                        <TNOTE>
                            <SU>1</SU>
                             The numbers in parenthesis refer to the Notes following this Table.
                        </TNOTE>
                    </GPOTABLE>
                    <P>
                        <E T="04">Notes to Table on Deposition Techniques:</E>
                    </P>
                    <P>
                        <E T="03">1. The term “coating process” includes coating repair and refurbishing as well as original coating.</E>
                    </P>
                    <P>
                        <E T="03">2. The term “alloyed aluminide coating” includes single or multiple-step coatings in which an element or elements are deposited prior to or during application of the aluminide coating, even if these elements are deposited by another coating process. It does not, however, include the multiple use of single-step pack cementation processes to achieve alloyed aluminides.</E>
                    </P>
                    <P>
                        <E T="03">3. The term “noble metal modified aluminide” coating includes multiple-step coatings in which the noble metal or noble metals are laid down by some other coating process prior to application of the aluminide coating.</E>
                    </P>
                    <P>
                        <E T="03">4. The term “mixtures thereof” includes infiltrated material, graded compositions, co-deposits and multilayer deposits and are obtained by one or more of the coating processes specified in the Table.</E>
                    </P>
                    <P>
                        <E T="03">5. MCrAlX refers to a coating alloy where M equals cobalt, iron, nickel or combinations thereof and X equals hafnium, yttrium, silicon, tantalum in any amount or other intentional additions over 0.01% by weight in various proportions and combinations, except:</E>
                    </P>
                    <P>
                        <E T="03">a. CoCrAlY coatings which contain less than 22% by weight of chromium, less than 7% by weight of aluminum and less than 2% by weight of yttrium;</E>
                    </P>
                    <P>
                        <E T="03">b. CoCrAlY coatings which contain 22 to 24% by weight of chromium, 10 to 12% by weight of aluminum and 0.5 to 0.7% by weight of yttrium; or</E>
                    </P>
                    <P>
                        <E T="03">c. NiCrAlY coatings which contain 21 to 23% by weight of chromium, 10 to 12% by weight of aluminum and 0.9 to 1.1% by weight of yttrium.</E>
                    </P>
                    <P>
                        <E T="03">6. The term “aluminum alloys” refers to alloys having an ultimate tensile strength of 190 MPa or more measured at 293 K (20 °C).</E>
                    </P>
                    <P>
                        <E T="03">7. The term “corrosion resistant steel” refers to AISI (American Iron and Steel Institute) 300 series or equivalent national standard steels.</E>
                    </P>
                    <P>
                        <E T="03">8. “Refractory metals and alloys” include the following metals and their alloys: Niobium (columbium), molybdenum, tungsten and tantalum.</E>
                    </P>
                    <P>
                        <E T="03">9. “Sensor window materials”, as follows: Alumina, silicon, germanium, zinc sulfide, zinc selenide, gallium arsenide, diamond, gallium phosphide, sapphire and the following metal halides: Sensor window materials of more than 40 mm diameter for zirconium fluoride and hafnium fluoride.</E>
                    </P>
                    <P>
                        <E T="03">10. Category 2 does not include “technology” for single-step pack cementation of solid airfoils.</E>
                    </P>
                    <P>
                        <E T="03">11. “Polymers”, as follows: Polyimide, polyester, polysulfide, polycarbonates and polyurethanes.</E>
                    </P>
                    <P>
                        <E T="03">12. “Modified zirconia” refers to additions of other metal oxides, (e.g., calcia, magnesia, yttria, hafnia, rare earth oxides) to zirconia in order to stabilize certain crystallographic phases and phase compositions. Thermal barrier coatings made of zirconia, modified with calcia or magnesia by mixing or fusion, are not controlled.</E>
                    </P>
                    <P>
                        <E T="03">13. “Titanium alloys” refers only to aerospace alloys having an ultimate tensile strength of 900 MPa or more measured at 293 K (20 °C).</E>
                    </P>
                    <P>
                        <E T="03">14. “Low-expansion glasses” refers to glasses which have a coefficient of thermal expansion of 1 × 10</E>
                        <E T="53">−7</E>
                          
                        <E T="03">K</E>
                        <E T="53">−1</E>
                          
                        <E T="03">or less measured at 293 K (20 °C).</E>
                    </P>
                    <P>
                        <E T="03">15. “Dielectric layers” are coatings constructed of multi-layers of insulator materials in which the interference properties of a design composed of materials of various refractive indices are used to reflect, transmit or absorb various wavelength bands. Dielectric layers refers to more than four dielectric layers or dielectric/metal “composite” layers.</E>
                    </P>
                    <P>
                        <E T="03">16. “Cemented tungsten carbide” does not include cutting and forming tool materials consisting of tungsten carbide/(cobalt, nickel), titanium carbide/(cobalt, nickel), chromium carbide/nickel-chromium and chromium carbide/nickel.</E>
                    </P>
                    <P>
                        <E T="03">
                            17. “Technology” for depositing diamond-like carbon on any of the following is not controlled: Magnetic disk drives and heads, equipment for the manufacture of disposables, valves for faucets, acoustic diaphragms for speakers, engine parts for automobiles, cutting tools, punching-pressing 
                            <PRTPAGE P="58622"/>
                            dies, office automation equipment, microphones, medical devices or molds, for casting or molding of plastics, manufactured from alloys containing less than 5% beryllium.
                        </E>
                    </P>
                    <P>
                        <E T="03">18. “Silicon carbide” does not include cutting and forming tool materials.</E>
                    </P>
                    <P>
                        <E T="03">19. Ceramic substrates, as used in this entry, does not include ceramic materials containing 5% by weight, or greater, clay or cement content, either as separate constituents or in combination.</E>
                    </P>
                    <P>
                        <E T="04">Technical Note to Table on Deposition Techniques:</E>
                          
                        <E T="03">Processes specified in Column 1 of the Table are defined as follows:</E>
                    </P>
                    <P>
                        <E T="03">a. Chemical Vapor Deposition (CVD) is an overlay coating or surface modification coating process wherein a metal, alloy, “composite”, dielectric or ceramic is deposited upon a heated substrate. Gaseous reactants are decomposed or combined in the vicinity of a substrate resulting in the deposition of the desired elemental, alloy or compound material on the substrate. Energy for this decomposition or chemical reaction process may be provided by the heat of the substrate, a glow discharge plasma, or “laser” irradiation.</E>
                    </P>
                    <P>
                        <E T="04">Note 1:</E>
                          
                        <E T="03">CVD includes the following processes: Directed gas flow out-of-pack deposition, pulsating CVD, controlled nucleation thermal decomposition (CNTD), plasma enhanced or plasma assisted CVD processes.</E>
                    </P>
                    <P>
                        <E T="04">Note 2:</E>
                          
                        <E T="03">Pack denotes a substrate immersed in a powder mixture.</E>
                    </P>
                    <P>
                        <E T="04">Note 3:</E>
                          
                        <E T="03">The gaseous reactants used in the out-of-pack process are produced using the same basic reactions and parameters as the pack cementation process, except that the substrate to be coated is not in contact with the powder mixture.</E>
                    </P>
                    <P>
                        <E T="03">b. Thermal Evaporation-Physical Vapor Deposition (TE-PVD) is an overlay coating process conducted in a vacuum with a pressure less than 0.1 Pa wherein a source of thermal energy is used to vaporize the coating material. This process results in the condensation, or deposition, of the evaporated species onto appropriately positioned substrates. The addition of gases to the vacuum chamber during the coating process to synthesize compound coatings is an ordinary modification of the process. The use of ion or electron beams, or plasma, to activate or assist the coating's deposition is also a common modification in this technique. The use of monitors to provide in-process measurement of optical characteristics and thickness of coatings can be a feature of these processes. Specific TE-PVD processes are as follows:</E>
                    </P>
                    <P>
                        <E T="03">1. Electron Beam PVD uses an electron beam to heat and evaporate the material which forms the coating;</E>
                    </P>
                    <P>
                        <E T="03">2. Ion Assisted Resistive Heating PVD employs electrically resistive heating sources in combination with impinging ion beam(s) to produce a controlled and uniform flux of evaporated coating species;</E>
                    </P>
                    <P>
                        <E T="03">3. “Laser” Vaporization uses either pulsed or continuous wave “laser” beams to vaporize the material which forms the coating;</E>
                    </P>
                    <P>
                        <E T="03">4. Cathodic Arc Deposition employs a consumable cathode of the material which forms the coating and has an arc discharge established on the surface by a momentary contact of a ground trigger. Controlled motion of arcing erodes the cathode surface creating a highly ionized plasma. The anode can be either a cone attached to the periphery of the cathode, through an insulator, or the chamber. Substrate biasing is used for non line-of-sight deposition.</E>
                    </P>
                    <P>
                        <E T="04">Note:</E>
                          
                        <E T="03">This definition does not include random cathodic arc deposition with non-biased substrates.</E>
                    </P>
                    <P>
                        <E T="03">5. Ion Plating is a special modification of a general TE-PVD process in which a plasma or an ion source is used to ionize the species to be deposited, and a negative bias is applied to the substrate in order to facilitate the extraction of the species from the plasma. The introduction of reactive species, evaporation of solids within the process chamber, and the use of monitors to provide in-process measurement of optical characteristics and thicknesses of coatings are ordinary modifications of the process.</E>
                    </P>
                    <P>
                        <E T="03">c. Pack Cementation is a surface modification coating or overlay coating process wherein a substrate is immersed in a powder mixture (a pack), that consists of:</E>
                    </P>
                    <P>
                        <E T="03">1. The metallic powders that are to be deposited (usually aluminum, chromium, silicon or combinations thereof);</E>
                    </P>
                    <P>
                        <E T="03">2. An activator (normally a halide salt); and</E>
                    </P>
                    <P>
                        <E T="03">3. An inert powder, most frequently alumina.</E>
                    </P>
                    <P>
                        <E T="04">Note:</E>
                          
                        <E T="03">The substrate and powder mixture is contained within a retort which is heated to between 1,030 K (757 °C) to 1,375 K (1,102 °C) for sufficient time to deposit the coating.</E>
                    </P>
                    <P>
                        <E T="03">d. Plasma Spraying is an overlay coating process wherein a gun (spray torch) which produces and controls a plasma accepts powder or wire coating materials, melts them and propels them towards a substrate, whereon an integrally bonded coating is formed. Plasma spraying constitutes either low pressure plasma spraying or high velocity plasma spraying.</E>
                    </P>
                    <P>
                        <E T="04">Note 1:</E>
                          
                        <E T="03">Low pressure means less than ambient atmospheric pressure.</E>
                    </P>
                    <P>
                        <E T="04">Note 2:</E>
                          
                        <E T="03">High velocity refers to nozzle-exit gas velocity exceeding 750 m/s calculated at 293 K (20 ° C) at 0.1 MPa.</E>
                    </P>
                    <P>
                        <E T="03">e. Slurry Deposition is a surface modification coating or overlay coating process wherein a metallic or ceramic powder with an organic binder is suspended in a liquid and is applied to a substrate by either spraying, dipping or painting, subsequent air or oven drying, and heat treatment to obtain the desired coating.</E>
                    </P>
                    <P>
                        <E T="03">f. Sputter Deposition is an overlay coating process based on a momentum transfer phenomenon, wherein positive ions are accelerated by an electric field towards the surface of a target (coating material). The kinetic energy of the impacting ions is sufficient to cause target surface atoms to be released and deposited on an appropriately positioned substrate.</E>
                    </P>
                    <P>
                        <E T="04">Note 1:</E>
                          
                        <E T="03">The Table refers only to triode, magnetron or reactive sputter deposition which is used to increase adhesion of the coating and rate of deposition and to radio frequency (RF) augmented sputter deposition used to permit vaporization of non-metallic coating materials.</E>
                    </P>
                    <P>
                        <E T="04">Note 2:</E>
                          
                        <E T="03">Low-energy ion beams (less than 5 keV) can be used to activate the deposition.</E>
                    </P>
                    <P>
                        <E T="03">g. Ion Implantation is a surface modification coating process in which the element to be alloyed is ionized, accelerated through a potential gradient and implanted into the surface region of the substrate. This includes processes in which ion implantation is performed simultaneously with electron beam physical vapor deposition or sputter deposition.</E>
                    </P>
                    <P>
                        <E T="03">Accompanying Technical Information to Table on Deposition Techniques:</E>
                    </P>
                    <P>
                        <E T="03">1. Technical information for pretreatments of the substrates listed in the Table, as follows:</E>
                    </P>
                    <P>
                        <E T="03">a. Chemical stripping and cleaning bath cycle parameters, as follows:</E>
                    </P>
                    <P>
                        <E T="03">1. Bath composition;</E>
                    </P>
                    <P>
                        <E T="03">a. For the removal of old or defective coatings corrosion product or foreign deposits;</E>
                    </P>
                    <P>
                        <E T="03">b. For preparation of virgin substrates;</E>
                    </P>
                    <P>
                        <E T="03">2. Time in bath;</E>
                    </P>
                    <P>
                        <E T="03">3. Temperature of bath;</E>
                    </P>
                    <P>
                        <E T="03">4. Number and sequences of wash cycles;</E>
                    </P>
                    <P>
                        <E T="03">b. Visual and macroscopic criteria for acceptance of the cleaned part;</E>
                    </P>
                    <P>
                        <E T="03">c. Heat treatment cycle parameters, as follows:</E>
                    </P>
                    <P>
                        <E T="03">1. Atmosphere parameters, as follows:</E>
                    </P>
                    <P>
                        <E T="03">a. Composition of the atmosphere;</E>
                    </P>
                    <P>
                        <E T="03">b. Pressure of the atmosphere;</E>
                    </P>
                    <P>
                        <E T="03">2. Temperature for heat treatment;</E>
                    </P>
                    <P>
                        <E T="03">3. Time of heat treatment;</E>
                    </P>
                    <P>
                        <E T="03">d. Substrate surface preparation parameters, as follows:</E>
                    </P>
                    <P>
                        <E T="03">1. Grit blasting parameters, as follows:</E>
                    </P>
                    <P>
                        <E T="03">a. Grit composition;</E>
                    </P>
                    <P>
                        <E T="03">b. Grit size and shape;</E>
                    </P>
                    <P>
                        <E T="03">c. Grit velocity;</E>
                    </P>
                    <P>
                        <E T="03">2. Time and sequence of cleaning cycle after grit blast;</E>
                    </P>
                    <P>
                        <E T="03">3. Surface finish parameters;</E>
                    </P>
                    <P>
                        <E T="03">4. Application of binders to promote adhesion;</E>
                    </P>
                    <P>
                        <E T="03">e. Masking technique parameters, as follows:</E>
                    </P>
                    <P>
                        <E T="03">1. Material of mask;</E>
                    </P>
                    <P>
                        <E T="03">2. Location of mask;</E>
                    </P>
                    <P>
                        <E T="03">2. Technical information for in situ quality assurance techniques for evaluation of the coating processes listed in the Table, as follows:</E>
                    </P>
                    <P>
                        <E T="03">a. Atmosphere parameters, as follows:</E>
                    </P>
                    <P>
                        <E T="03">1. Composition of the atmosphere;</E>
                    </P>
                    <P>
                        <E T="03">2. Pressure of the atmosphere;</E>
                    </P>
                    <P>
                        <E T="03">b. Time parameters;</E>
                    </P>
                    <P>
                        <E T="03">c. Temperature parameters;</E>
                    </P>
                    <P>
                        <E T="03">d. Thickness parameters;</E>
                    </P>
                    <P>
                        <E T="03">e. Index of refraction parameters;</E>
                    </P>
                    <P>
                        <E T="03">f. Control of composition;</E>
                    </P>
                    <P>
                        <E T="03">3. Technical information for post deposition treatments of the coated substrates listed in the Table, as follows:</E>
                    </P>
                    <P>
                        <E T="03">a. Shot peening parameters, as follows:</E>
                    </P>
                    <P>
                        <E T="03">1. Shot composition;</E>
                    </P>
                    <P>
                        <E T="03">2. Shot size;</E>
                    </P>
                    <P>
                        <E T="03">3. Shot velocity;</E>
                    </P>
                    <P>
                        <E T="03">b. Post shot peening cleaning parameters;</E>
                    </P>
                    <P>
                        <E T="03">c. Heat treatment cycle parameters, as follows:</E>
                    </P>
                    <P>
                        <E T="03">1. Atmosphere parameters, as follows:</E>
                    </P>
                    <P>
                        <E T="03">a. Composition of the atmosphere;</E>
                    </P>
                    <P>
                        <E T="03">b. Pressure of the atmosphere;</E>
                    </P>
                    <P>
                        <E T="03">2. Time-temperature cycles;</E>
                        <PRTPAGE P="58623"/>
                    </P>
                    <P>
                        <E T="03">d. Post heat treatment visual and macroscopic criteria for acceptance of the coated substrates;</E>
                    </P>
                    <P>
                        <E T="03">4. Technical information for quality assurance techniques for the evaluation of the coated substrates listed in the Table, as follows:</E>
                    </P>
                    <P>
                        <E T="03">a. Statistical sampling criteria;</E>
                    </P>
                    <P>
                        <E T="03">b. Microscopic criteria for:</E>
                    </P>
                    <P>
                        <E T="03">1. Magnification;</E>
                    </P>
                    <P>
                        <E T="03">2. Coating thickness, uniformity;</E>
                    </P>
                    <P>
                        <E T="03">3. Coating integrity;</E>
                    </P>
                    <P>
                        <E T="03">4. Coating composition;</E>
                    </P>
                    <P>
                        <E T="03">5. Coating and substrates bonding;</E>
                    </P>
                    <P>
                        <E T="03">6. Microstructural uniformity.</E>
                    </P>
                    <P>
                        <E T="03">c. Criteria for optical properties assessment (measured as a function of wavelength):</E>
                    </P>
                    <P>
                        <E T="03">1. Reflectance;</E>
                    </P>
                    <P>
                        <E T="03">2. Transmission;</E>
                    </P>
                    <P>
                        <E T="03">3. Absorption;</E>
                    </P>
                    <P>
                        <E T="03">4. Scatter;</E>
                    </P>
                    <P>
                        <E T="03">5. Technical information and parameters related to specific coating and surface modification processes listed in the Table, as follows:</E>
                    </P>
                    <P>
                        <E T="03">a. For Chemical Vapor Deposition (CVD):</E>
                    </P>
                    <P>
                        <E T="03">1. Coating source composition and formulation;</E>
                    </P>
                    <P>
                        <E T="03">2. Carrier gas composition;</E>
                    </P>
                    <P>
                        <E T="03">3. Substrate temperature;</E>
                    </P>
                    <P>
                        <E T="03">4. Time-temperature-pressure cycles;</E>
                    </P>
                    <P>
                        <E T="03">5. Gas control and part manipulation;</E>
                    </P>
                    <P>
                        <E T="03">b. For Thermal Evaporation-Physical Vapor Deposition (PVD):</E>
                    </P>
                    <P>
                        <E T="03">1. Ingot or coating material source composition;</E>
                    </P>
                    <P>
                        <E T="03">2. Substrate temperature;</E>
                    </P>
                    <P>
                        <E T="03">3. Reactive gas composition;</E>
                    </P>
                    <P>
                        <E T="03">4. Ingot feed rate or material vaporization rate;</E>
                    </P>
                    <P>
                        <E T="03">5. Time-temperature-pressure cycles;</E>
                    </P>
                    <P>
                        <E T="03">6. Beam and part manipulation;</E>
                    </P>
                    <P>
                        <E T="03">7. “Laser” parameters, as follows:</E>
                    </P>
                    <P>
                        <E T="03">a. Wave length;</E>
                    </P>
                    <P>
                        <E T="03">b. Power density;</E>
                    </P>
                    <P>
                        <E T="03">c. Pulse length;</E>
                    </P>
                    <P>
                        <E T="03">d. Repetition ratio;</E>
                    </P>
                    <P>
                        <E T="03">e. Source;</E>
                    </P>
                    <P>
                        <E T="03">c. For Pack Cementation:</E>
                    </P>
                    <P>
                        <E T="03">1. Pack composition and formulation;</E>
                    </P>
                    <P>
                        <E T="03">2. Carrier gas composition;</E>
                    </P>
                    <P>
                        <E T="03">3. Time-temperature-pressure cycles;</E>
                    </P>
                    <P>
                        <E T="03">d. For Plasma Spraying:</E>
                    </P>
                    <P>
                        <E T="03">1. Powder composition, preparation and size distributions;</E>
                    </P>
                    <P>
                        <E T="03">2. Feed gas composition and parameters;</E>
                    </P>
                    <P>
                        <E T="03">3. Substrate temperature;</E>
                    </P>
                    <P>
                        <E T="03">4. Gun power parameters;</E>
                    </P>
                    <P>
                        <E T="03">5. Spray distance;</E>
                    </P>
                    <P>
                        <E T="03">6. Spray angle;</E>
                    </P>
                    <P>
                        <E T="03">7. Cover gas composition, pressure and flow rates;</E>
                    </P>
                    <P>
                        <E T="03">8. Gun control and part manipulation;</E>
                    </P>
                    <P>
                        <E T="03">e. For Sputter Deposition:</E>
                    </P>
                    <P>
                        <E T="03">1. Target composition and fabrication;</E>
                    </P>
                    <P>
                        <E T="03">2. Geometrical positioning of part and target;</E>
                    </P>
                    <P>
                        <E T="03">3. Reactive gas composition;</E>
                    </P>
                    <P>
                        <E T="03">4. Electrical bias;</E>
                    </P>
                    <P>
                        <E T="03">5. Time-temperature-pressure cycles;</E>
                    </P>
                    <P>
                        <E T="03">6. Triode power;</E>
                    </P>
                    <P>
                        <E T="03">7. Part manipulation;</E>
                    </P>
                    <P>
                        <E T="03">f. For Ion Implantation:</E>
                    </P>
                    <P>
                        <E T="03">1. Beam control and part manipulation;</E>
                    </P>
                    <P>
                        <E T="03">2. Ion source design details;</E>
                    </P>
                    <P>
                        <E T="03">3. Control techniques for ion beam and deposition rate parameters;</E>
                    </P>
                    <P>
                        <E T="03">4. Time-temperature-pressure cycles.</E>
                    </P>
                    <P>
                        <E T="03">g. For Ion Plating:</E>
                    </P>
                    <P>
                        <E T="03">1. Beam control and part manipulation;</E>
                    </P>
                    <P>
                        <E T="03">2. Ion source design details;</E>
                    </P>
                    <P>
                        <E T="03">3. Control techniques for ion beam and deposition rate parameters;</E>
                    </P>
                    <P>
                        <E T="03">4. Time-temperature-pressure cycles;</E>
                    </P>
                    <P>
                        <E T="03">5. Coating material feed rate and vaporization rate;</E>
                    </P>
                    <P>
                        <E T="03">6. Substrate temperature;</E>
                    </P>
                    <P>
                        <E T="03">7. Substrate bias parameters.</E>
                    </P>
                </EXTRACT>
                <AMDPAR>6. In Supplement No. 1 to part 774, Category 9, ECCN 9D001 is revised to read as follows:</AMDPAR>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        <E T="04">9D001 “Software”, not specified in 9D003 or 9D004, “specially designed” or modified for the “development” of equipment or “technology” controlled by ECCN 9A001 to 9A004, 9A012, 9A101 (except for items in 9A101.b that are “subject to the ITAR,” see 22 CFR part 121), 9A106.d. or .e, 9A110, or 9A120, 9B (except for ECCNs 9B604, 9B610, 9B619, 9B990, and 9B991), or ECCN 9E003.</E>
                    </FP>
                    <HD SOURCE="HD1">License Requirements</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">Reason for Control:</E>
                         NS, MT, AT
                    </FP>
                    <GPOTABLE COLS="2" OPTS="L0,tp0,i1" CDEF="s10,r10">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1">
                                <E T="03">Control(s)</E>
                            </CHED>
                            <CHED H="1">
                                <E T="03">Country chart</E>
                                <LI>
                                    <E T="03">(See Supp. No. 1 to part 738)</E>
                                </LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">NS applies to “software” for equipment controlled by 9A001 to 9A004, 9A012, 9B001 to 9B010, and technology controlled by 9E003</ENT>
                            <ENT>NS Column 1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">MT applies to “software” for equipment controlled by 9B116 for MT reasons</ENT>
                            <ENT>MT Column 1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">AT applies to entire entry</ENT>
                            <ENT>AT Column 1.</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD1">Reporting Requirements</HD>
                    <P>See § 743.1 of the EAR for reporting requirements for exports under License Exceptions, and Validated End-User authorizations.</P>
                    <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">TSR:</E>
                         N/A.
                    </FP>
                    <HD SOURCE="HD1">Special Conditions for STA</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">STA:</E>
                         See § 740.20(b)(2)(viii) of License Exception STA for limitations on availability of STA for Commerce Control List Category 9 items in this entry.
                    </FP>
                    <HD SOURCE="HD1">List of Items Controlled</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">Related Controls</E>
                         “Software” that is “required” for the “development” of items specified in ECCNs 9A005 to 9A011, 9A101.b (except for items that are subject to the EAR), 9A103 to 9A105, 9A106.a, .b, and .c, 9A107 to 9A109, 9A110 (for items that are “specially designed” for use in missile systems and subsystems), and 9A111 to 9A119 is “subject to the ITAR.”
                    </FP>
                    <FP SOURCE="FP-1">
                        <E T="03">Related Definitions:</E>
                         N/A
                    </FP>
                    <FP SOURCE="FP-1">Items:</FP>
                    <P>The list of items controlled is contained in the ECCN heading.</P>
                </EXTRACT>
                <AMDPAR>7. In Supplement No. 1 to part 774, Category 9, ECCN 9D002 is revised to read as follows:</AMDPAR>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        <E T="04">9D002 “Software”, not specified in 9D003 or 9D004, “specially designed” or modified for the “production” of equipment controlled by ECCN 9A001 to 9A004, 9A012, 9A101 (except for items in 9A101.b that are “subject to the ITAR,” see 22 CFR part 121), 9A106.d or .e, 9A110, or 9A120, 9B (except for ECCNs 9B604, 9B610, 9B619, 9B990, and 9B991).</E>
                    </FP>
                    <HD SOURCE="HD1">License Requirements</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">Reason for Control:</E>
                         NS, MT, AT
                    </FP>
                    <GPOTABLE COLS="2" OPTS="L0,tp0,i1" CDEF="s10,r10">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1">
                                <E T="03">Control(s)</E>
                            </CHED>
                            <CHED H="1">
                                <E T="03">Country chart</E>
                                <LI>
                                    <E T="03">(See Supp. No. 1 to part 738)</E>
                                </LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">NS applies to “software” for equipment controlled by 9A001 to 9A004, 9A012, 9B001 to 9B010</ENT>
                            <ENT>NS Column 1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">MT applies to “software” for equipment controlled by 9B116 for MT reasons</ENT>
                            <ENT>MT Column 1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">AT applies to entire entry</ENT>
                            <ENT>AT Column 1.</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD1">Reporting Requirements</HD>
                    <P>See § 743.1 of the EAR for reporting requirements for exports under License Exceptions, and Validated End-User authorizations.</P>
                    <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">TSR:</E>
                         N/A.
                    </FP>
                    <HD SOURCE="HD1">Special Conditions for STA</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">STA:</E>
                         See § 740.20(b)(2)(viii) of License Exception STA for limitations on availability of STA for Commerce Control List Category 9 items in this entry.
                    </FP>
                    <HD SOURCE="HD1">List of Items Controlled</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">Related Controls:</E>
                         “Software” that is “required” for the “production” of items specified in ECCNs 9A005 to 9A011, 9A101.b (except for items that are subject to the EAR), 9A103 to 9A105, 9A106.a, .b, and .c, 9A107 to 9A109, 9A110 (for items that are “specially designed” for use in missile systems and subsystems), and 9A111 to 9A119 is “subject to the ITAR.”
                    </FP>
                    <FP SOURCE="FP-1">
                        <E T="03">Related Definitions:</E>
                         N/A
                    </FP>
                    <FP SOURCE="FP-1">Items:</FP>
                    <P>The list of items controlled is contained in the ECCN heading.</P>
                </EXTRACT>
                <AMDPAR>8. In Supplement No. 1 to part 774, Category 9, ECCN 9D004 is revised to read as follows:</AMDPAR>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        <E T="04">9D004 Other “software” as follows (see List of Items Controlled).</E>
                        <PRTPAGE P="58624"/>
                    </FP>
                    <HD SOURCE="HD1">License Requirements</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">Reason for Control:</E>
                         NS, AT
                    </FP>
                    <GPOTABLE COLS="2" OPTS="L0,tp0,i1" CDEF="s10,r10">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1">
                                <E T="03">Control(s)</E>
                            </CHED>
                            <CHED H="1">
                                <E T="03">Country chart</E>
                                <LI>
                                    <E T="03">(See Supp. No. 1 to part 738)</E>
                                </LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">NS applies to entire entry</ENT>
                            <ENT>NS Column 1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">AT applies to entire entry</ENT>
                            <ENT>AT Column 1.</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">TSR:</E>
                         N/A.
                    </FP>
                    <HD SOURCE="HD1">Special Conditions for STA</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">STA:</E>
                         See § 740.20(b)(2)(viii) of License Exception STA for limitations on availability of STA for Commerce Control List Category 9 items in this entry.
                    </FP>
                    <HD SOURCE="HD1">List of Items Controlled</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">Related Controls:</E>
                         See also 9D104.
                    </FP>
                    <FP SOURCE="FP-1">
                        <E T="03">Related Definitions:</E>
                         N/A
                    </FP>
                    <FP SOURCE="FP-1">
                        <E T="03">Items:</E>
                    </FP>
                    <P>a. 2D or 3D viscous “software”, validated with wind tunnel or flight test data required for detailed engine flow modelling;</P>
                    <P>b. “Software” for testing aero gas turbine engines, assemblies, “parts” or “components”, having all of the following:</P>
                    <P>b.1. “Specially designed” for testing any of the following:</P>
                    <P>
                        b.1.a. Aero gas turbine engines, assemblies or components, incorporating “technology” specified by 9E003.a, 9E003.h or 9E003.i; 
                        <E T="03">or</E>
                    </P>
                    <P>
                        b.1.b. Multi-stage compressors providing either bypass or core flow, specially designed for aero gas turbine engines incorporating “technology” specified by 9E003.a or 9E003.h; 
                        <E T="03">and</E>
                    </P>
                    <P>b.2. “Specially designed” for all of the following:</P>
                    <P>
                        b.2.a. Acquisition and processing of data, in real time; 
                        <E T="03">and</E>
                    </P>
                    <P>
                        b.2.b. Feedback control of the test article or test conditions (
                        <E T="03">e.g.,</E>
                         temperature, pressure, flow rate) while the test is in progress;
                    </P>
                    <P>
                        <E T="04">Note:</E>
                          
                        <E T="03">9D004.b does not specify software for operation of the test facility or operator safety (e.g., overspeed shutdown, fire detection and suppression), or production, repair or maintenance acceptance-testing limited to determining if the item has been properly assembled or repaired.</E>
                    </P>
                    <P>c. “Software” “specially designed” to control directional solidification or single crystal material growth in equipment specified by 9B001.a or 9B001.c;</P>
                    <P>d. [RESERVED]</P>
                    <P>e. “Software” “specially designed” or modified for the operation of items specified by 9A012;</P>
                    <P>f. “Software” “specially designed” to design the internal cooling passages of aero gas turbine engine blades, vanes and “tip shrouds”;</P>
                    <P>g. “Software” having all of the following:</P>
                    <P>
                        g.1. “Specially designed” to predict aero thermal, aeromechanical and combustion conditions in aero gas turbine engines; 
                        <E T="03">and</E>
                    </P>
                    <P>g.2. Theoretical modeling predictions of the aero thermal, aeromechanical and combustion conditions, which have been validated with actual turbine engine (experimental or production) performance data.</P>
                </EXTRACT>
                <AMDPAR>9. In supplement No. 1 to part 774, Category 9, ECCN 9E001 is revised to read as follows:</AMDPAR>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        <E T="04">9E001 “Technology” according to the General Technology Note for the “development” of equipment or “software”, controlled by 9A001.b, 9A004, 9A012, 9B (except for ECCNs 9B604, 9B610, 9B619, 9B990 and 9B991), or ECCN 9D001 to 9D004, 9D101, or 9D104.</E>
                    </FP>
                    <HD SOURCE="HD1">License Requirements</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">Reason for Control:</E>
                         NS, MT, AT
                    </FP>
                    <GPOTABLE COLS="2" OPTS="L0,tp0,i1" CDEF="s10,r10">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1">
                                <E T="03">Control(s)</E>
                            </CHED>
                            <CHED H="1">
                                <E T="03">Country chart</E>
                                <LI>
                                    <E T="03">(See Supp. No. 1 to part 738)</E>
                                </LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">NS applies to “technology” for items controlled by 9A001.b, 9A004, 9A012, 9B001 to 9B010, 9D001 to 9D004 for NS reasons</ENT>
                            <ENT>NS Column 1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">MT applies to “technology” for items controlled by 9A012, 9B001, 9B002, 9B003, 9B004, 9B005, 9B007, 9B104, 9B105, 9B106, 9B115, 9B116, 9B117, 9D001, 9D002, 9D003, or 9D004 for MT reasons</ENT>
                            <ENT>MT Column 1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">AT applies to entire entry</ENT>
                            <ENT>AT Column 1.</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD1">Reporting Requirements</HD>
                    <P>See § 743.1 of the EAR for reporting requirements for exports under License Exceptions, and Validated End-User authorizations.</P>
                    <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">TSR:</E>
                         N/A
                    </FP>
                    <HD SOURCE="HD1">Special Conditions for STA</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">STA:</E>
                         See § 740.20(b)(2)(viii) of License Exception STA for limitations on availability of STA for Commerce Control List Category 9 items in this entry.
                    </FP>
                    <HD SOURCE="HD1">List of Items Controlled</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">Related Controls:</E>
                         (1) See also 9E101 and 1E002.f (for controls on “technology” for the repair of controlled structures, laminates or materials). (2) “Technology” required for the “development” of equipment described in ECCNs 9A005 to 9A011 or “software” described in ECCNs 9D103 and 9D105 is “subject to the ITAR.”
                    </FP>
                    <FP SOURCE="FP-1">
                        <E T="03">Related Definitions:</E>
                         N/A
                    </FP>
                    <FP SOURCE="FP-1">
                        <E T="03">Items:</E>
                    </FP>
                    <P>The list of items controlled is contained in the ECCN heading.</P>
                </EXTRACT>
                <AMDPAR>10. In supplement No. 1 to part 774, Category 9, ECCN 9E002 is revised to read as follows:</AMDPAR>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        <E T="04">9E002 “Technology” according to the General Technology Note for the “production” of “equipment” controlled by ECCN 9A001.b, 9A004 or 9B (except for ECCNs 9B117, 9B604, 9B610, 9B619, 9B990, and 9B991).</E>
                    </FP>
                    <HD SOURCE="HD1">License Requirements</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">Reason for Control:</E>
                         NS, MT, AT
                    </FP>
                    <GPOTABLE COLS="2" OPTS="L0,tp0,i1" CDEF="s10,r10">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1">
                                <E T="03">Control(s)</E>
                            </CHED>
                            <CHED H="1">
                                <E T="03">Country chart</E>
                                <LI>
                                    <E T="03">(See Supp. No. 1 to part 738)</E>
                                </LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">NS applies to entire entry</ENT>
                            <ENT>NS Column 1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">MT applies to “technology” for equipment controlled by 9B001, 9B002, 9B003, 9B004, 9B005, 9B007, 9B104, 9B105, 9B106, 9B115 or 9B116 for MT reasons</ENT>
                            <ENT>MT Column 1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">AT applies to entire entry</ENT>
                            <ENT>AT Column 1.</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD1">Reporting Requirements</HD>
                    <P>See § 743.1 of the EAR for reporting requirements for exports under License Exceptions, and Validated End-User authorizations.</P>
                    <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">TSR:</E>
                         N/A
                    </FP>
                    <HD SOURCE="HD1">Special Conditions for STA</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">STA:</E>
                         See § 740.20(b)(2)(viii) of License Exception STA for limitations on availability of STA for Commerce Control List Category 9 items in this entry.
                    </FP>
                    <HD SOURCE="HD1">List of Items Controlled</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">Related Controls:</E>
                         (1) See also 9E102. (2) See also 1E002.f for “technology” for the repair of controlled structures, laminates or materials. (3) “Technology” that is required for the “production” of equipment described in ECCNs 9A005 to 9A011 is “subject to the ITAR.”
                    </FP>
                    <FP SOURCE="FP-1">
                        <E T="03">Related Definitions:</E>
                         N/A
                    </FP>
                    <FP SOURCE="FP-1">
                        <E T="03">Items:</E>
                    </FP>
                    <P>The list of items controlled is contained in the ECCN heading.</P>
                </EXTRACT>
                <AMDPAR>11. In supplement No. 1 to part 774, Category 9, ECCN 9E003 is revised to read as follows:</AMDPAR>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        <E T="04">9E003 Other “technology” as follows (see List of Items Controlled).</E>
                    </FP>
                    <HD SOURCE="HD1">License Requirements</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">Reason for Control:</E>
                         NS, SI, AT
                    </FP>
                    <GPOTABLE COLS="2" OPTS="L0,tp0,i1" CDEF="s10,r10">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1">
                                <E T="03">Control(s)</E>
                            </CHED>
                            <CHED H="1">
                                <E T="03">Country chart</E>
                                <LI>
                                    <E T="03">(See Supp. No. 1 to part 738)</E>
                                </LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">NS applies to entire entry</ENT>
                            <ENT>NS Column 1.</ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="58625"/>
                            <ENT I="01">SI applies to 9E003.a.1 through a.8,.h, .i, and .k</ENT>
                            <ENT>See § 742.14 of the EAR for additional information.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">AT applies to entire entry</ENT>
                            <ENT>AT Column 1.</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD1">Reporting Requirements</HD>
                    <P>See § 743.1 of the EAR for reporting requirements for exports under License Exceptions, and Validated End-User authorizations.</P>
                    <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">TSR:</E>
                         N/A
                    </FP>
                    <HD SOURCE="HD1">Special Conditions for STA</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">STA:</E>
                         See § 740.20(b)(2)(viii) of License Exception STA for limitations on availability of STA for Commerce Control List Category 9 items in this entry.
                    </FP>
                    <HD SOURCE="HD1">List of Items Controlled</HD>
                    <FP SOURCE="FP-1">
                        <E T="03">Related Controls:</E>
                         (1) Hot section “technology” specifically designed, modified, or equipped for military uses or purposes, or developed principally with U.S. Department of Defense funding, is “subject to the ITAR” (see 22 CFR parts 120 through 130). (2) “Technology” is subject to the EAR when actually applied to a commercial “aircraft” engine program. Exporters may seek to establish commercial application either on a case-by-case basis through submission of documentation demonstrating application to a commercial program in requesting an export license from the Department Commerce in respect to a specific export, or in the case of use for broad categories of “aircraft,” engines, “parts” or “components,” a commodity jurisdiction determination from the Department of State.
                    </FP>
                    <FP SOURCE="FP-1">
                        <E T="03">Related Definitions:</E>
                         N/A
                    </FP>
                    <FP SOURCE="FP-1">
                        <E T="03">Items:</E>
                    </FP>
                    <P>a. “Technology” “required” for the “development” or “production” of any of the following gas turbine engine “parts,” “components” or systems:</P>
                    <P>a.1. Gas turbine blades, vanes or “tip shrouds”, made from directionally solidified (DS) or single crystal (SC) alloys and having (in the 001 Miller Index Direction) a stress-rupture life exceeding 400 hours at 1,273 K (1,000 °C) at a stress of 200 MPa, based on the average property values;</P>
                    <P>
                        <E T="04">Technical Note:</E>
                          
                        <E T="03">For the purposes of 9E003.a.1, stress-rupture life testing is typically conducted on a test specimen.</E>
                    </P>
                    <P>a.2. Combustors having any of the following:</P>
                    <P>a.2.a. `Thermally decoupled liners' designed to operate at `combustor exit temperature' exceeding 1,883K (1,610 °C);</P>
                    <P>a.2.b. Non-metallic liners;</P>
                    <P>
                        a.2.c. Non-metallic shells; 
                        <E T="03">or</E>
                    </P>
                    <P>a.2.d. Liners designed to operate at `combustor exit temperature' exceeding 1,883 K (1,610 °C) and having holes that meet the parameters specified by 9E003.c;</P>
                    <P>
                        <E T="04">Note:</E>
                          
                        <E T="03">The “required” “technology” for holes in 9E003.a.2 is limited to the derivation of the geometry and location of the holes.</E>
                    </P>
                    <P>
                        <E T="04">Technical Notes:</E>
                    </P>
                    <P>
                        <E T="03">1. `Thermally decoupled liners' are liners that feature at least a support structure designed to carry mechanical loads and a combustion facing structure designed to protect the support structure from the heat of combustion. The combustion facing structure and support structure have independent thermal displacement (mechanical displacement due to thermal load) with respect to one another, i.e., they are thermally decoupled.</E>
                    </P>
                    <P>
                        <E T="03">2. `Combustor exit temperature' is the bulk average gas path total (stagnation) temperature between the combustor exit plane and the leading edge of the turbine inlet guide vane (i.e., measured at engine station T40 as defined in SAE ARP 755A) when the engine is running in a “steady state mode” of operation at the certificated maximum continuous operating temperature.</E>
                    </P>
                    <P>
                        <E T="04">N.B.:</E>
                          
                        <E T="03">See 9E003.c for “technology” “required” for manufacturing cooling holes.</E>
                    </P>
                    <P>a.3. “Parts” or “components,” that are any of the following:</P>
                    <P>a.3.a. Manufactured from organic “composite” materials designed to operate above 588 K (315 °C);</P>
                    <P>a.3.b. Manufactured from any of the following:</P>
                    <P>a.3.b.1. Metal “matrix” “composites” reinforced by any of the following:</P>
                    <P>a.3.b.1.a. Materials controlled by 1C007;</P>
                    <P>
                        a.3.b.1.b. “Fibrous or filamentary materials” specified by 1C010; 
                        <E T="03">or</E>
                    </P>
                    <P>
                        a.3.b.1.c. Aluminides specified by 1C002.a; 
                        <E T="03">or</E>
                    </P>
                    <P>
                        a.3.b.2. Ceramic “matrix” “composites” specified by 1C007; 
                        <E T="03">or</E>
                    </P>
                    <P>a.3.c. Stators, vanes, blades, tip seals (shrouds), rotating blings, rotating blisks or `splitter ducts', that are all of the following:</P>
                    <P>a.3.c.1. Not specified in 9E003.a.3.a;</P>
                    <P>
                        a.3.c.2. Designed for compressors or fans; 
                        <E T="03">and</E>
                    </P>
                    <P>a.3.c.3. Manufactured from material controlled by 1C010.e with resins controlled by 1C008;</P>
                    <P>
                        <E T="04">Technical Note:</E>
                          
                        <E T="03">A `splitter duct' performs the initial separation of the air-mass flow between the bypass and core sections of the engine.</E>
                    </P>
                    <P>a.4. Uncooled turbine blades, vanes or “tip shrouds” designed to operate at a `gas path temperature' of 1,373 K (1,100 °C) or more;</P>
                    <P>a.5. Cooled turbine blades, vanes or “tip-shrouds”, other than those described in 9E003.a.1, designed to operate at a `gas path temperature' of 1,693 K (1,420 °C) or more;</P>
                    <P>
                        <E T="04">Technical Note:</E>
                          
                        <E T="03">`Gas path temperature' is the bulk average gas path total (stagnation) temperature at the leading edge plane of the turbine component when the engine is running in a “steady state mode” of operation at the certificated or specified maximum continuous operating temperature.</E>
                    </P>
                    <P>a.6. Airfoil-to-disk blade combinations using solid state joining;</P>
                    <P>a.7. [Reserved];</P>
                    <P>
                        a.8. `Damage tolerant' gas turbine engine rotor “parts” or “components” using powder metallurgy materials controlled by 1C002.b; 
                        <E T="03">or</E>
                    </P>
                    <P>
                        <E T="04">Technical Note:</E>
                          
                        <E T="03">`Damage tolerant' “parts” and “components” are designed using methodology and substantiation to predict and limit crack growth.</E>
                    </P>
                    <P>a.9. [Reserved]</P>
                    <P>
                        <E T="04">N.B.:</E>
                          
                        <E T="03">For “FADEC systems”, see 9E003.h.</E>
                    </P>
                    <P>a.10. [Reserved]</P>
                    <P>
                        <E T="04">N.B.:</E>
                          
                        <E T="03">For adjustable flow path geometry, see 9E003.i.</E>
                    </P>
                    <P>a.11. `Fan blades' having all of the following:</P>
                    <P>a.11.a. 20% or more of the total volume being one or more closed cavities containing vacuum or gas only; and</P>
                    <P>
                        a.11.b. One or more closed cavities having a volume of 5 cm
                        <SU>3</SU>
                         or larger;
                    </P>
                    <P>
                        <E T="04">Technical Note:</E>
                          
                        <E T="03">For the purposes of 9E003.a.11, a `fan blade' is the aerofoil portion of the rotating stage or stages, which provide both compressor and bypass flow in a gas turbine engine.</E>
                    </P>
                    <P>b. “Technology” “required” for the “development” or “production” of any of the following:</P>
                    <P>
                        b.1. Wind tunnel aero-models equipped with non-intrusive sensors capable of transmitting data from the sensors to the data acquisition system; 
                        <E T="03">or</E>
                    </P>
                    <P>b.2. “Composite” propeller blades or prop-fans, capable of absorbing more than 2,000 kW at flight speeds exceeding Mach 0.55;</P>
                    <P>c. “Technology” “required” for manufacturing cooling holes, in gas turbine engine “parts” or “components” incorporating any of the “technologies” specified by 9E003.a.1, 9E003.a.2 or 9E003.a.5, and having any of the following:</P>
                    <P>c.1. Having all of the following:</P>
                    <P>
                        c.1.a. Minimum `cross-sectional area' less than 0.45 mm
                        <SU>2</SU>
                        ;
                    </P>
                    <P>
                        c.1.b. `Hole shape ratio' greater than 4.52; 
                        <E T="03">and</E>
                    </P>
                    <P>
                        c.1.c. `Incidence angle' equal to or less than 25°; 
                        <E T="03">or</E>
                    </P>
                    <P>c.2. Having all of the following:</P>
                    <P>
                        c.2.a. Minimum `cross-sectional area' less than 0.12 mm
                        <SU>2</SU>
                        ;
                    </P>
                    <P>
                        c.2.b. `Hole shape ratio' greater than 5.65; 
                        <E T="03">and</E>
                    </P>
                    <P>c.2.c. `Incidence angle' more than 25°;</P>
                    <P>
                        <E T="04">Note:</E>
                          
                        <E T="03">9E003.c does not apply to “technology” for manufacturing constant radius cylindrical holes that are straight through and enter and exit on the external surfaces of the component.</E>
                    </P>
                    <P>
                        <E T="04">Technical Notes:</E>
                    </P>
                    <P>
                        <E T="03">1. For the purposes of 9E003.c, the `cross-sectional area' is the area of the hole in the plane perpendicular to the hole axis.</E>
                    </P>
                    <P>
                        <E T="03">2. For the purposes of 9E003.c, `hole shape ratio' is the nominal length of the axis of the hole divided by the square root of its minimum `cross-sectional area'.</E>
                    </P>
                    <P>
                        <E T="03">3. For the purposes of 9E003.c, `incidence angle' is the acute angle measured between the plane tangential to the airfoil surface and the hole axis at the point where the hole axis enters the airfoil surface.</E>
                    </P>
                    <P>
                        <E T="03">4. Techniques for manufacturing holes in 9E003.c include “laser” beam machining, water jet machining, Electro-Chemical Machining (ECM).</E>
                    </P>
                    <P>
                        d. “Technology” “required” for the “development” or “production” of helicopter power transfer systems or tilt rotor or tilt wing “aircraft” power transfer systems;
                        <PRTPAGE P="58626"/>
                    </P>
                    <P>e. “Technology” for the “development” or “production” of reciprocating diesel engine ground vehicle propulsion systems having all of the following:</P>
                    <P>
                        e.1. `Box volume' of 1.2 m
                        <SU>3</SU>
                         or less;
                    </P>
                    <P>
                        e.2. An overall power output of more than 750 kW based on 80/1269/EEC, ISO 2534 or national equivalents; 
                        <E T="03">and</E>
                    </P>
                    <P>
                        e.3. Power density of more than 700 kW/m
                        <SU>3</SU>
                         of `box volume';
                    </P>
                    <P>
                        <E T="04">Technical Note:</E>
                          
                        <E T="03">`Box volume' is the product of three perpendicular dimensions measured in the following way:</E>
                    </P>
                    <P>
                        <E T="03">Length: The length of the crankshaft from front flange to flywheel face;</E>
                    </P>
                    <P>
                        <E T="03">Width: The widest of any of the following:</E>
                    </P>
                    <P>
                        <E T="03">a. The outside dimension from valve cover to valve cover;</E>
                    </P>
                    <P>
                        <E T="03">b. The dimensions of the outside edges of the cylinder heads; or</E>
                    </P>
                    <P>
                        <E T="03">c. The diameter of the flywheel housing;</E>
                    </P>
                    <P>
                        <E T="03">Height: The largest of any of the following:</E>
                    </P>
                    <P>
                        <E T="03">a. The dimension of the crankshaft center-line to the top plane of the valve cover (or cylinder head) plus twice the stroke; or</E>
                    </P>
                    <P>
                        <E T="03">b. The diameter of the flywheel housing.</E>
                    </P>
                    <P>f. “Technology” “required” for the “production” of “specially designed” “parts” or “components” for high output diesel engines, as follows:</P>
                    <P>f.1. “Technology” “required” for the “production” of engine systems having all of the following “parts” and “components” employing ceramics materials controlled by 1C007:</P>
                    <P>f.1.a Cylinder liners;</P>
                    <P>f.1.b. Pistons;</P>
                    <P>
                        f.1.c. Cylinder heads; 
                        <E T="03">and</E>
                    </P>
                    <P>f.1.d. One or more other “part” or “component” (including exhaust ports, turbochargers, valve guides, valve assemblies or insulated fuel injectors);</P>
                    <P>f.2. “Technology” “required” for the “production” of turbocharger systems with single-stage compressors and having all of the following:</P>
                    <P>f.2.a. Operating at pressure ratios of 4:1 or higher;</P>
                    <P>
                        f.2.b. Mass flow in the range from 30 to 130 kg per minute; 
                        <E T="03">and</E>
                    </P>
                    <P>f.2.c. Variable flow area capability within the compressor or turbine sections;</P>
                    <P>
                        f.3. “Technology” “required” for the “production” of fuel injection systems with a “specially designed” multifuel (
                        <E T="03">e.g.,</E>
                         diesel or jet fuel) capability covering a viscosity range from diesel fuel (2.5 cSt at 310.8 K (37.8 °C)) down to gasoline fuel (0.5 cSt at 310.8 K (37.8 °C)) and having all of the following:
                    </P>
                    <P>
                        f.3.a. Injection amount in excess of 230 mm
                        <SU>3</SU>
                         per injection per cylinder; 
                        <E T="03">and</E>
                    </P>
                    <P>f.3.b. Electronic control features “specially designed” for switching governor characteristics automatically depending on fuel property to provide the same torque characteristics by using the appropriate sensors;</P>
                    <P>g. “Technology” “required” for the development” or “production” of `high output diesel engines' for solid, gas phase or liquid film (or combinations thereof) cylinder wall lubrication and permitting operation to temperatures exceeding 723 K (450 °C), measured on the cylinder wall at the top limit of travel of the top ring of the piston;</P>
                    <P>
                        <E T="04">Technical Note:</E>
                          
                        <E T="03">`High output diesel engines' are diesel engines with a specified brake mean effective pressure of 1.8 MPa or more at a speed of 2,300 rpm, provided the rated speed is 2,300 rpm or more.</E>
                    </P>
                    <P>h. “Technology” for gas turbine engine “FADEC systems” as follows:</P>
                    <P>
                        h.1. “Development” “technology” for deriving the functional requirements for the “parts” or “components” necessary for the “FADEC system” to regulate engine thrust or shaft power (
                        <E T="03">e.g.,</E>
                         feedback sensor time constants and accuracies, fuel valve slew rate);
                    </P>
                    <P>h.2. “Development” or “production” “technology” for control and diagnostic “parts” or “components” unique to the “FADEC system” and used to regulate engine thrust or shaft power;</P>
                    <P>h.3. “Development” “technology” for the control law algorithms, including “source code”, unique to the “FADEC system” and used to regulate engine thrust or shaft power;</P>
                    <P>
                        <E T="04">Note:</E>
                          
                        <E T="03">9E003.h does not apply to technical data related to engine-“aircraft” integration required by civil aviation authorities of one or more Wassenaar Arrangement Participating States (see Supplement No. 1 to part 743 of the EAR) to be published for general airline use (e.g., installation manuals, operating instructions, instructions for continued airworthiness) or interface functions (e.g., input/output processing, airframe thrust or shaft power demand).</E>
                    </P>
                    <P>i. “Technology” for adjustable flow path systems designed to maintain engine stability for gas generator turbines, fan or power turbines, or propelling nozzles, as follows:</P>
                    <P>i.1. “Development” “technology” for deriving the functional requirements for the “parts” or “components” that maintain engine stability;</P>
                    <P>i.2. “Development” or “production” “technology” for “parts” or “components” unique to the adjustable flow path system and that maintain engine stability;</P>
                    <P>i.3. “Development” “technology” for the control law algorithms, including “source code”, unique to the adjustable flow path system and that maintain engine stability;</P>
                    <P>
                        <E T="04">Note:</E>
                          
                        <E T="03">9E003.i does not apply to “technology” for any of the following:</E>
                    </P>
                    <P>
                        a. 
                        <E T="03">Inlet guide vanes;</E>
                    </P>
                    <P>
                        b. 
                        <E T="03">Variable pitch fans or prop-fans;</E>
                    </P>
                    <P>
                        c. 
                        <E T="03">Variable compressor vanes;</E>
                    </P>
                    <P>
                        d. 
                        <E T="03">Compressor bleed valves; or</E>
                    </P>
                    <P>
                        e. 
                        <E T="03">Adjustable flow path geometry for reverse thrust.</E>
                    </P>
                    <P>j. “Technology” “required” for the “development” of wing-folding systems designed for fixed-wing “aircraft” powered by gas turbine engines.</P>
                    <P>
                        <E T="04">N.B.:</E>
                          
                        <E T="03">For “technology” “required” for the “development” of wing-folding systems designed for fixed-wing “aircraft” specified in USML Category VIII(a), see USML Category VIII(i).</E>
                    </P>
                    <P>k. “Technology” not otherwise controlled in 9E003.a.1 through a.8, a.10, and .h and used in the “development”, “production”, or overhaul of hot section “parts” or “components” of civil derivatives of military engines controlled on the USML.</P>
                </EXTRACT>
                <SIG>
                    <NAME>Matthew S. Borman,</NAME>
                    <TITLE>Deputy Assistant Secretary for Export Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-21954 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-33-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">LIBRARY OF CONGRESS</AGENCY>
                <SUBAGY>Copyright Royalty Board</SUBAGY>
                <CFR>37 CFR Part 385</CFR>
                <DEPDOC>[Docket No. 21-CRB-0001-PR (2023-2027)]</DEPDOC>
                <SUBJECT>Determination of Rates and Terms for Making and Distributing Phonorecords (Phonorecords IV)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Copyright Royalty Board, Library of Congress.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule; second reopening of comment period.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Because a comment filed by settling parties included additional material (in particular a memorandum of understanding) that relates to statements in some of the comments the Copyright Royalty Judges received, the Judges are reopening the comment period for an additional 30 days. The proposed rule published for comment sets certain rates and terms applicable during the period beginning January 1, 2023, and ending December 31, 2027, for the section 115 statutory license for making and distributing phonorecords of nondramatic musical works and is based on regulations proposed pursuant to a partial settlement among the settling parties.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The comment period for the proposed rule published June 25, 2021, at 86 FR 33601, which was reopened on July 29, 2021, at 86 FR 40793, is reopened a second time. Comments are due no later than November 22, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may send comments, identified by docket number 21-CRB-0001-PR (2023-2027), online through eCRB at 
                        <E T="03">https://app.crb.gov.</E>
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         To send your comment through eCRB, if you don't have a user account, you will first need to register for an account and wait for your registration to be approved. Approval of user accounts is only available during business hours. Once you have an approved account, you can only sign in and file your comment after setting up multi-factor authentication, which can be done at any time of day. All comments must include the Copyright Royalty Board name and the docket number for this proposed rule. All properly filed comments will appear 
                        <PRTPAGE P="58627"/>
                        without change in eCRB at 
                        <E T="03">https://app.crb.gov,</E>
                         including any personal information provided.
                    </P>
                    <P>
                        <E T="03">Docket:</E>
                         For access to the docket to read background documents or comments received, go to eCRB at 
                        <E T="03">https://app.crb.gov</E>
                         and perform a case search for docket 21-CRB-0001-PR (2023-2027).
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Anita Blaine, CRB Program Specialist, 202-707-7658, 
                        <E T="03">crb@loc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>On June 25, 2021, the Copyright Royalty Judges published for comment proposed regulations (arising from a partial settlement) that set rates and terms applicable during the period beginning January 1, 2023, and ending December 31, 2027, for the section 115 statutory license for making and distributing phonorecords of nondramatic musical works. Comments were due by July 26, 2021. 86 FR 33601 (Jun. 25, 2021). As some filers experienced technical difficulties filing their comments in eCRB, the Judges extended the deadline for filing comments to August 10, 2021. 86 FR 40793 (July 29, 2021).</P>
                <P>On August 10, 2021, the final day of the extended comment period, the National Music Publishers' Association, Inc., (“NMPA”) and Nashville Songwriters Association International (“Copyright Owner Participants”), and Sony Music Entertainment, UMG Recordings, Inc. and Warner Music Group Corp. (“Joint Record Company Participants”), jointly submitted comments regarding the proposed rule (“Joint Submission”). Attached to the Joint Submission, as Exhibit C, was a Memorandum of Understanding (“MOU”) between the Joint Record Company Participants and the Recording Industry Association of America, Inc., on the one hand, and NMPA and certain music publishing companies, on the other.</P>
                <P>
                    The Joint Submission included arguments that the MOU is irrelevant to the Judges' consideration of the proposed partial settlement and proposed regulations and that the MOU does not call into question the reasonableness of the proposed partial settlement and proposed regulations. Because interested parties other than those who submitted the Joint Submission may have been unable to adequately view or comment upon the MOU prior to the close of the Judges' extended comment period, the Judges are reopening the comment period. The Judges will allow 
                    <E T="03">30</E>
                     days for comments regarding the impact, if any, that the MOU should have on the Judges' consideration of whether the proposed partial settlement and proposed regulations provide a reasonable basis for setting statutory rates and terms.
                </P>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>Jesse M. Feder,</NAME>
                    <TITLE>Chief Copyright Royalty Judge.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23097 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 1410-72-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 52</CFR>
                <DEPDOC>[EPA-R09-OAR-2021-0410; FRL-8791-01-Region 9]</DEPDOC>
                <SUBJECT>Air Plan Limited Approval and Limited Disapproval; California; Air Resources Board; Volatile Organic Compounds</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Environmental Protection Agency (EPA) is proposing action on a revision to the California Air Resources Board (CARB) portion of the California State Implementation Plan (SIP). This revision concerns emissions of volatile organic compounds (VOCs) from vapor recovery systems of gasoline cargo tanks. We are proposing a limited approval and limited disapproval of a statewide rule to regulate this emission source under the Clean Air Act (CAA or the Act), and are also proposing to approve the recission of a different statewide rule from the California SIP that previously regulated this emission source. We are taking comments on this proposal and plan to follow with a final action.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before November 22, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit your comments, identified by Docket ID No. EPA-R09-OAR-2021-0410 at 
                        <E T="03">https://www.regulations.gov.</E>
                         For comments submitted at 
                        <E T="03">Regulations.gov,</E>
                         follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from 
                        <E T="03">Regulations.gov.</E>
                         The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (
                        <E T="03">i.e.</E>
                         on the web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit 
                        <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets.</E>
                         If you need assistance in a language other than English or if you are a person with disabilities 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>
                        La Kenya Evans, EPA Region IX, 75 Hawthorne St., San Francisco, CA 94105. By phone: (415) 972-3245 or by email at 
                        <E T="03">evans.lakenya@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <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. The State's Submittal</FP>
                    <FP SOURCE="FP1-2">A. What rule and rescission did the State submit?</FP>
                    <FP SOURCE="FP1-2">B. Are there other versions of this rule?</FP>
                    <FP SOURCE="FP1-2">C. What is the purpose of the submitted rule and rescission?</FP>
                    <FP SOURCE="FP-2">II. The EPA's Evaluation and Action</FP>
                    <FP SOURCE="FP1-2">A. How is the EPA evaluating the rule and rescission?</FP>
                    <FP SOURCE="FP1-2">B. Does the rule and rescission meet the evaluation criteria?</FP>
                    <FP SOURCE="FP1-2">C. What are the rule deficiencies?</FP>
                    <FP SOURCE="FP1-2">D. The EPA's Recommendations To Further Improve the Rule</FP>
                    <FP SOURCE="FP1-2">E. Public Comment and Proposed 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. The State's Submittal</HD>
                <HD SOURCE="HD2">A. What rule and rescission did the State submit?</HD>
                <P>
                    Table 1 lists the SIP revisions addressed by this proposal with the dates they were locally acted on by the California Air Resources Board (CARB). CARB submitted the SIP revisions to the EPA on August 22, 2018.
                    <PRTPAGE P="58628"/>
                </P>
                <GPOTABLE COLS="4" OPTS="L2,nj,i1" CDEF="s50,r50,r50,xs100">
                    <TTITLE>Table 1—Submitted SIP Revisions</TTITLE>
                    <BOXHD>
                        <CHED H="1">Regulation or provision</CHED>
                        <CHED H="1">Regulation title or subject</CHED>
                        <CHED H="1">Date of local action</CHED>
                        <CHED H="1">State requested action</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">California Code of Regulations, Title 17, Division 3, Chapter 1, Subchapter 8, Article 1, Section 94014</ENT>
                        <ENT>Certification of Vapor Recovery Systems for Cargo Tanks</ENT>
                        <ENT>Adopted on 07/25/13</ENT>
                        <ENT>Addition to the SIP.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Certification Procedure CP-204</ENT>
                        <ENT>Certification Procedure for Vapor Recovery Systems of Cargo Tanks</ENT>
                        <ENT>Referenced in Section 94014 and adopted on 11/7/2014</ENT>
                        <ENT>Addition to the SIP.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Test Procedure TP-204.1</ENT>
                        <ENT>Determination of Five Minute Static Pressure Performance of Vapor Recovery Systems of Cargo Tanks</ENT>
                        <ENT>Referenced in Section 94014 and adopted on 11/7/2014</ENT>
                        <ENT>Addition to the SIP.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Test Procedure TP-204.2</ENT>
                        <ENT>Determination of One Minute Static Pressure Performance of Vapor Recovery Systems of Cargo Tanks</ENT>
                        <ENT>Referenced in Section 94014 and adopted on 05/27/2014</ENT>
                        <ENT>Addition to the SIP.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Test Procedure TP-204.3</ENT>
                        <ENT>Determination of Leak(s)</ENT>
                        <ENT>Referenced in Section 94014 and adopted on 11/7/2014</ENT>
                        <ENT>Addition to the SIP.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">California Code of Regulations, Title 17, Division 3, Chapter 1, Subchapter 8, Article 1, Section 94004</ENT>
                        <ENT>Certification of Vapor Recovery Systems—Gasoline Delivery Tanks</ENT>
                        <ENT>Repealed on 06/29/1995</ENT>
                        <ENT>Recission from the SIP.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Method 2-5</ENT>
                        <ENT>Certification and Test Procedures for Vapor Recovery Systems of Gasoline Delivery Tanks</ENT>
                        <ENT>Referenced in Section 94004 and effective on 09/1/1982</ENT>
                        <ENT>Recission from the SIP.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>On February 22, 2019, the submittal for CARB's California Code of Regulations (CCR), Title 17, Division 3, Chapter 1, Subchapter 8, Article 1, Section 94014 (Section 94014) and request to rescind CCR, Title 17, Division 3, Chapter 1, Subchapter 8, Article 1, Section 94004 (Section 94004) were both deemed by operation of law to meet the completeness criteria in 40 CFR part 51 Appendix V, which must be met before formal EPA review.</P>
                <HD SOURCE="HD2">B. Are there other versions of this rule?</HD>
                <P>
                    Vapor recovery systems for tanker trucks (hereafter referred to as “cargo tanks”) were previously regulated by Section 94004, which required the use of Method 2-5 “Certification of Vapor Recovery Systems—Gasoline Delivery Tanks.” Section 94004 was approved into the SIP on July 8, 1982.
                    <SU>1</SU>
                    <FTREF/>
                     CARB submitted an amended version of Method 2-5 on January 20, 1983, and EPA approved it into the SIP on May 3, 1984.
                    <SU>2</SU>
                    <FTREF/>
                     On June 29, 1995, CARB repealed Section 94004 and adopted a new statewide version of the rule at Section 94014, “Certification of Vapor Recovery Systems for Cargo Tanks.” Section 94014 has since been amended on multiple occasions, most recently on July 25, 2013, and consists of a certification procedure and three test procedures that are incorporated by reference. CARB submitted the revised rule, certification procedure, and test procedures to the EPA on August 22, 2018, for inclusion into the SIP.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         47 FR 29668.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         49 FR 18829.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">C. What is the purpose of the submitted rule and rescission?</HD>
                <P>Emissions of VOCs contribute to the production of ground-level ozone and smog, which harm human health and the environment. Section 110(a) of the CAA requires states to submit regulations that control VOC emissions.</P>
                <P>Section 41954 of the California Health and Safety Code requires that CARB “[inspect] and [test] . . . certified vapor recovery systems upon installation during the permit process and [conduct] regular inspections to check that systems are operating as certified.” Section 94014 allows gasoline vapor recovery systems for cargo tanks to be certified in accordance with Certification Procedure CP-204, “Certification Procedure for Vapor Recovery Systems of Cargo Tanks” (CP-204). The rule incorporates CP-204 by reference. Section 94014 also incorporates by reference three test procedures: Test Procedure TP-204.1, “Determination of Five Minute Static Pressure Performance of Vapor Recovery Systems of Cargo Tanks” (TP-204.1), Test Procedure TP-204.2, “Determination of One Minute Static Pressure Performance of Vapor Recovery Systems of Cargo Tanks” (TP-204.2), and Test Procedure TP-204.3, “Determination of Leak(s)” (TP-204.3).</P>
                <P>CP-204 describes the process for certifying cargo tanks with a system that recovers vapors during the loading and unloading of gasoline. This certification procedure establishes performance standards or specifications for cargo tanks, including trucks and trailers that transport gasoline. TP-204.1 is a detailed test procedure used to determine the five-minute static pressure associated with the dispensing of any fluid. This test procedure is written to reflect application to the hydrocarbon vapors associated with the dispensing of gasoline tested annually. TP-204.2 is used to determine the daily static pressure performance standard, or one-minute standard, associated with the dispensing of any fluid. TP-204.2 is written to reflect application to the hydrocarbon vapors associated with the dispensing of gasoline. TP-204.3 is intended to locate and classify leaks only, and not as a direct measure of mass emission rates from individual sources. This test procedure is used to determine the leak-tightness of vapor control systems used in (a) loading of gasoline cargo tanks; (b) loading without taking the delivery tank out of service; (c) at gasoline terminals and bulk plants at any time; and (d) when the system does not create back-pressure in excess of the pressure limits of the cargo tank certification test. The EPA's technical support document (TSD) has more information about this rule.</P>
                <P>The rescission of Section 94004 will remove the rule from the SIP and Section 94014 will replace it.</P>
                <HD SOURCE="HD1">II. The EPA's Evaluation and Action</HD>
                <HD SOURCE="HD2">A. How is the EPA evaluating the rule and rescission?</HD>
                <P>
                    Rules in the SIP must be enforceable (see CAA section 110(a)(2)), must not interfere with applicable requirements concerning attainment and reasonable further progress or other CAA requirements (see CAA section 110(l)), 
                    <PRTPAGE P="58629"/>
                    and must not modify certain SIP control requirements in nonattainment areas without ensuring equivalent or greater emissions reductions (see CAA section 193).
                </P>
                <P>Generally, SIP rules must require Reasonably Available Control Technology (RACT) for each category of sources covered by a Control Techniques Guidelines (CTG) document as well as each major source of VOCs in ozone nonattainment areas classified as Moderate or above (see CAA section 182(b)(2)).</P>
                <P>Guidance and policy documents that we used to evaluate enforceability, revision/relaxation and rule stringency requirements for the applicable criteria pollutants include the following:</P>
                <P>1. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,” EPA, May 25, 1988 (the Bluebook, revised January 11, 1990).</P>
                <P>2. “Guidance Document for Correcting Common VOC &amp; Other Rule Deficiencies,” EPA Region 9, August 21, 2001 (the Little Bluebook).</P>
                <P>3. “Control of Volatile Organic Compound Leaks from Gasoline Tank Trucks and Vapor Collection Systems,” EPA-450/2-78-051, December 1978.</P>
                <P>4. 40 CFR part 63.11092(f)(1), “Standards of Performance for Bulk Gasoline Terminals,” 76 FR 4156 (January 24, 2011).</P>
                <P>5. 40 CFR part 60.501, “National Emission Standards for Hazardous Air Pollutants for Source Category: Gasoline Distribution Bulk Terminals, Bulk Plants, and Pipeline Facilities,” 48 FR 37590 (August 18, 1983).</P>
                <P>6. Maricopa County Air Pollution Control Regulations Rule 352, “Gasoline Cargo Tank Testing and Use,” 60 FR 46024 (September 5, 1995).</P>
                <P>7. Maryland Department of Environment Rule 26.11.13.05, “Gasoline Leaks from Tank Trucks” 80 FR 45892 (August 3, 2015).</P>
                <P>8. Maryland Department of Environment Method 1008, “Gasoline Vapor Leak Detection Procedure by Combustible Gas Detector,” incorporated by reference COMAR 26.11.01.04C, 78 FR 5290 (January 25, 2013).</P>
                <P>9. Texas Commission on Environmental Quality Rule 115.235, “Approved Test Methods” 65 FR 79745 (December 20, 2000).</P>
                <P>10. Illinois Environmental Protection Agency Rule 215.584, “Gasoline Delivery Vessels,” 55 FR 26814 (July 29, 1990).</P>
                <HD SOURCE="HD2">B. Does the rule and rescission meet the evaluation criteria?</HD>
                <P>The replacement of Section 94004 by Section 94014 meets CAA requirements, and Section 94014 is consistent with relevant guidance regarding enforceability, RACT, and SIP revisions. Section 94014 is more stringent than Section 94004 as it includes a certification procedure that describes the instructions for determining performance standards, specifications, and test procedures for vapor recovery systems. In addition, Section 94014 is more stringent than the EPA's 1978 CTG and is as stringent as comparable rules for this source category established in other states. Therefore, Section 94014 implements RACT. The TSD has more information on our evaluation.</P>
                <HD SOURCE="HD2">C. What are the rule deficiencies?</HD>
                <P>
                    The director's discretion in Section 94014 does not satisfy the requirements of section 110 of the Act and prevents full approval of the SIP revision. Documents submitted for inclusion into the SIP should not include unbounded director's discretion that allows the State to approve alternatives to the applicable SIP without following the SIP revision process described in CAA section 110. CP-204 Section 5.4 allows the CARB Executive Officer to approve an alternative test procedure that meets the equivalency criteria established by EPA Method 301. This is acceptable as EPA Method 301 is “a set of procedures . . . to validate a candidate test method as an alternative to a required test method based on established precision and bias criteria.” 
                    <SU>3</SU>
                    <FTREF/>
                     For situations where Method 301 is not directly applicable, CP-204 Section 5.4 allows the CARB Executive Officer, without approval from the EPA, to “. . . establish equivalence based on the concepts of comparison with established method and statistical analysis of bias and variance.” This authority is then incorporated by reference in TP-204.1, TP-204.2, and TP-204.3. Without further specificity regarding the criteria the Executive Officer will use to determine when such alternative test procedures, for which Method 301 is not applicable, will be approved, CP-204 Section 5.4 represents an instance of unbounded director's discretion and constitutes a SIP deficiency. The TSD has more information regarding this deficiency.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         EPA Method 301, “Field Validation of Pollutant Measurement Methods from Various Waste Media,” 85 FR 63394 (October 7, 2020).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">D. The EPA Recommendations To Further Improve the Rule</HD>
                <P>
                    The EPA recommends revising Section 94014 to address the deficiency discussed above. Such revisions could include additional detail regarding how to evaluate alternative test procedure requests when Method 301 is not applicable, or could add language resembling federal enforceability sections in CARB's consumer products regulations to further limit the extent of the Executive Officer's authority (17 CCR section 94506.5 and 17 CCR section 94517).
                    <E T="51">4 5</E>
                    <FTREF/>
                     The TSD includes other recommendations for the next time the state agency modifies the rule.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         74 FR 57074 (November 4, 2009).
                    </P>
                    <P>
                        <SU>5</SU>
                         79 FR 62346 (October 17, 2014).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">E. Public Comment and Proposed Action</HD>
                <P>As authorized in section 110(k)(3) of the Act, the EPA is proposing a limited approval and limited disapproval of the submitted rule. The limited disapproval for CP-204, Section 5.4 and its reference in TP-204.1, TP-204.2, and TP-204.3 is based on the enforceability issue identified in section (II)(C) of this notice. We will accept comments from the public on this proposal until November 22, 2021. If finalized, this action would incorporate the submitted rule into the SIP, including those provisions identified as deficient. If we finalize this disapproval, CAA section 110(c) would require the EPA to promulgate a federal implementation plan within 24 months unless we approve subsequent SIP revisions that correct the deficiencies identified in the final approval. In addition, final disapproval would trigger the offset sanction in CAA section 179(b)(2) 18 months after the effective date of a final disapproval, and the highway funding sanction in CAA section 179(b)(1) six months after the offset sanction is imposed. A sanction will not be imposed if the EPA determines that a subsequent SIP submission corrects the deficiencies identified in our final action before the applicable deadline. The EPA intends to work with CARB to correct the deficiency in a timely manner.</P>
                <P>
                    Note that the submitted rule has been adopted by CARB, and the EPA's final limited disapproval would not prevent the state agency from enforcing it. The limited disapproval also would not prevent any portion of the rule from being incorporated by reference into the federally enforceable SIP as discussed in a July 9, 1992 EPA memo found at: 
                    <E T="03">https://www.epa.gov/sites/production/files/2015-07/documents/procsip.pdf.</E>
                </P>
                <HD SOURCE="HD1">III. Incorporation by Reference</HD>
                <P>
                    In this rule, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with 
                    <PRTPAGE P="58630"/>
                    requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference Section 94014 and the associated certification procedure and test procedures as described in Table 1 of this preamble, and proposing to remove Section 94004 and Method 2-5 also as described in Table 1 from the SIP. The EPA has made, and will continue to make, these materials available through 
                    <E T="03">https://www.regulations.gov</E>
                     and at the EPA Region IX Office (please contact the person identified in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section of this preamble for more information).
                </P>
                <HD SOURCE="HD1">IV. Statutory and Executive Order Reviews</HD>
                <P>
                    Additional information about these statutes and Executive Orders can be found at 
                    <E T="03">http://www.epa.gov/laws-regulations/laws-and-executive-orders.</E>
                </P>
                <HD SOURCE="HD2">A. Executive Order 12866: Regulatory Planning and Review and Executive Order 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 PRA because this action 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: Coordination With Indian Tribal Governments</HD>
                <P>This action does not have tribal implications, as specified in Executive Order 13175, because 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, and will not impose substantial direct 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 Risks 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 not impose additional requirements beyond those imposed by state law.</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 and Advancement Act (NTTAA)</HD>
                <P>Section 12(d) of the NTTAA directs the EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. The EPA believes that this action is not subject to the requirements of section 12(d) of the NTTAA because application of those requirements would be inconsistent with the CAA.</P>
                <HD SOURCE="HD2">J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Population</HD>
                <P>The EPA lacks the discretionary authority to address environmental justice in this rulemaking.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 40 CFR Part 52</HD>
                    <P>Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements, Volatile organic compounds.</P>
                </LSTSUB>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P>
                        42 U.S.C. 7401 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: October 13, 2021.</DATED>
                    <NAME>Deborah Jordan,</NAME>
                    <TITLE>Acting Regional Administrator, Region IX.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-22716 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 52</CFR>
                <DEPDOC>[EPA-R09-OAR-2021-0638; FRL-9101-01-R9]</DEPDOC>
                <SUBJECT>Clean Air Plans; Base Year Emissions Inventories for the 2015 Ozone Standards; Arizona; Phoenix-Mesa and Yuma Nonattainment Areas</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Environmental Protection Agency (EPA) is proposing to approve, under the Clean Air Act (CAA), revisions to the Arizona State Implementation Plan (SIP) concerning the base year emissions inventory requirements for the Phoenix-Mesa ozone nonattainment area (“Phoenix-Mesa”) and Yuma ozone nonattainment area (“Yuma”) for the 2015 ozone national ambient air quality standards (NAAQS or “standard”).</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Any comments must arrive by November 22, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit your comments, identified by Docket ID No. EPA-R09-OAR-2021-0638 at 
                        <E T="03">https://www.regulations.gov.</E>
                         For comments submitted at 
                        <E T="03">Regulations.gov</E>
                        , follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from 
                        <E T="03">Regulations.gov</E>
                        . The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (
                        <E T="03">i.e.,</E>
                         on the web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section. 
                        <PRTPAGE P="58631"/>
                        For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit 
                        <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets.</E>
                         If you need assistance in a language other than English or if you are a person with disabilities 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>
                        Ben Leers, Air Planning Office (AIR-2), EPA Region IX, (415) 947-4279, 
                        <E T="03">Leers.Ben@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <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="FP1-2">A. Emissions Inventories</FP>
                    <FP SOURCE="FP1-2">B. State Submittals</FP>
                    <FP SOURCE="FP1-2">C. Public Notice and Hearing Requirements</FP>
                    <FP SOURCE="FP-2">II. Arizona's Emissions Inventories</FP>
                    <FP SOURCE="FP1-2">A. Baseline Emissions Inventory for the Phoenix-Mesa Nonattainment Area</FP>
                    <FP SOURCE="FP1-2">B. Baseline Emissions Inventory for the Yuma Nonattainment Area</FP>
                    <FP SOURCE="FP-2">III. EPA's Evaluation</FP>
                    <FP SOURCE="FP-2">IV. Proposed Action and Request for Public Comment</FP>
                    <FP SOURCE="FP-2">V. Statutory and Executive Order Reviews</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    On October 26, 2015, the EPA promulgated a revised 8-hour ozone NAAQS of 0.070 parts per million (ppm).
                    <SU>1</SU>
                    <FTREF/>
                     In accordance with section 107(d) of the CAA, the EPA must designate an area “nonattainment” if it is violating the NAAQS or if it is contributing to a violation of the NAAQS in a nearby area.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         80 FR 65292 (October 26, 2015).
                    </P>
                </FTNT>
                <P>
                    The EPA designated two areas in Arizona as nonattainment for the 2015 ozone NAAQS on June 4, 2018, effective August 3, 2018.
                    <SU>2</SU>
                    <FTREF/>
                     The Phoenix-Mesa nonattainment area (including Gila, Maricopa, and Pinal counties) and Yuma nonattainment area (including Yuma County) were classified as “Marginal” ozone nonattainment.
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         83 FR 25776.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">A. Emissions Inventories</HD>
                <P>
                    Sections 172(c)(3) and 182(a)(1) of the CAA require states to develop and submit, as a SIP revision, “base year” emissions inventories for all areas designated as nonattainment for an ozone NAAQS. The EPA finalized the 2015 ozone NAAQS SIP Requirements Rule (SRR) on December 6, 2018. The SRR established implementation requirements for the 2015 ozone NAAQS, including requirements for base year emissions inventories under CAA section 182(a)(1).
                    <SU>3</SU>
                    <FTREF/>
                     The SRR for the 2015 ozone NAAQS is codified at 40 CFR part 51, subpart CC, and the emissions inventory requirements are codified at 40 CFR 51.1315.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         83 FR 62998.
                    </P>
                </FTNT>
                <P>
                    An emissions inventory for ozone is an estimation of actual emissions of air pollutants that contribute to the formation of ozone in an area. Ozone is a gas that is formed by the reaction of volatile organic compounds (VOC) and oxides of nitrogen (NO
                    <E T="52">X</E>
                    ), referred to as ozone precursors, in the atmosphere in the presence of sunlight. Therefore, an emissions inventory for ozone focuses on the emissions of VOC and NO
                    <E T="52">X</E>
                    . VOC is emitted by many types of sources, including power plants, industrial sources, on-road and off-road mobile sources, smaller stationary sources collectively referred to as area sources, and biogenic sources. NO
                    <E T="52">X</E>
                     is primarily emitted by combustion sources, both stationary and mobile.
                </P>
                <P>
                    Emissions inventories provide emissions data that inform a variety of air quality planning tasks, including establishing baseline emissions levels, calculating emissions reduction targets needed to attain the NAAQS and to achieve reasonable further progress (RFP) toward attainment of the ozone standard,
                    <SU>4</SU>
                    <FTREF/>
                     determining emissions inputs for ozone air quality modeling analyses, and tracking emissions over time to determine progress toward achieving air quality and emissions reduction goals.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         The RFP requirements specified in CAA section 182(b)(1) apply to all areas classified as “Moderate” or higher ozone nonattainment. At the time of submittal of the Phoenix-Mesa and Yuma base year emissions inventory SIPs for the 2015 ozone NAAQS, the Phoenix-Mesa and Yuma areas were designated Marginal nonattainment for the 2015 ozone NAAQS and were therefore not required to demonstrate RFP toward attainment of the 2015 ozone NAAQS.
                    </P>
                </FTNT>
                <P>
                    For the 2015 ozone NAAQS, states are required to submit ozone season day emissions estimates for an inventory calendar year to be consistent with the baseline year for RFP plans as required by 40 CFR 51.1310(b).
                    <SU>5</SU>
                    <FTREF/>
                     Under 40 CFR 51.1310(b), for the 2015 ozone NAAQS, the RFP baseline year is the most recent calendar year for which a complete triennial inventory is required to be submitted to the EPA under 40 CFR 51 subpart A.
                    <SU>6</SU>
                    <FTREF/>
                     States may use an alternative baseline emissions inventory provided that the year selected corresponds with the year of the effective date of designation as nonattainment for that NAAQS. Ozone season day emissions are defined in 40 CFR 51.1300(q) as the average day's emissions for a typical ozone season work weekday. Under the definition in 40 CFR 51.1300(q), states are required to select the months in the ozone season and the days in the work week to be represented. Per EPA's 2017 guidance on emissions inventory development, the selected ozone season should be representative of the conditions leading to nonattainment.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         40 CFR 51.1315(a).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         83 FR 62998, 63034.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         EPA, “Emissions Inventory Guidance for Implementation of Ozone and Particulate Matter National Ambient Air Quality Standards (NAAQS) and Regional Haze Regulations” (May 2017), 75.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. State Submittals</HD>
                <P>On July 8, 2020, the Arizona Department of Environmental Quality (ADEQ) submitted a revision to the Arizona SIP titled “Maricopa Association of Governments (MAG) 2020 Eight-Hour Ozone Plan” (“2020 Phoenix-Mesa SIP Submittal”). The 2020 Phoenix-Mesa SIP Submittal includes a 2017 baseline emissions inventory for Phoenix-Mesa developed by the Maricopa Association of Governments (MAG) and supporting documentation regarding the development of the baseline emissions inventory.</P>
                <P>
                    On July 29, 2020, ADEQ submitted a revision to the Arizona SIP titled “Marginal Ozone Plan for the Yuma Nonattainment Area,” including a 2017 baseline emissions inventory for Yuma and supporting documentation regarding the development of the emissions inventory. The July 29, 2020 submittal did not include final amendments to the emissions statement rule in Arizona Administrative Code R18-2-327 and did not adequately satisfy the public notice requirements under 40 CFR 51.102. On December 22, 2020, ADEQ withdrew the July 29, 2020 submittal and submitted as a revision to the Arizona SIP another plan, also titled “Marginal Ozone Plan for the Yuma Nonattainment Area.” On July 1, 2021, Arizona provided a technical supplement to the Marginal Ozone Plan for the Yuma Nonattainment Area addressing comments and questions raised by the EPA following receipt of ADEQ's prior submittals.
                    <SU>8</SU>
                    <FTREF/>
                     Arizona's December 22, 2020 submittal and the July 1, 2021 supplement are collectively referred to herein as the “2020 Yuma SIP Submittal.” Where specifically 
                    <PRTPAGE P="58632"/>
                    referring to information provided in Arizona's supplement to the 2020 Yuma SIP Submittal, we refer to the July 1, 2021 supplement as the “2021 Yuma SIP Supplement.”
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Letter dated June 30, 2021, from Joseph Martini, Manager, Air Quality Improvement Planning Section, Air Quality Division, Arizona Department of Environmental Quality, to Ben Leers, Air Planning Office, Air Division, EPA Region IX. Transmitted via email dated July 1, 2021, from Farah Esmaeili, Environmental Senior Engineer, Technical Analysis Unit, Air Quality Division, Arizona Department of Environmental Quality to Ben Leers.
                    </P>
                </FTNT>
                <P>In this action, we are evaluating and proposing action on the 2020 Phoenix-Mesa SIP Submittal and the 2020 Yuma SIP Submittal.</P>
                <HD SOURCE="HD2">C. Public Notice and Hearing Requirements</HD>
                <P>CAA sections 110(a)(1) and 110(l) and 40 CFR 51.102 require states to provide reasonable notice and an opportunity for a public hearing prior to adoption of SIP revisions. Section 110(k)(1)(B) requires the EPA to determine whether a SIP submittal is complete within 60 days of receipt. Any plan that the EPA does not affirmatively determine to be complete or incomplete will become complete six months after the day of submittal by operation of law. A finding of completeness does not approve the submittal as part of the SIP, nor does it indicate that the submittal is approvable. It does start a 12-month clock for the EPA to act on the SIP submittal (see CAA section 110(k)(2)).</P>
                <P>The 2020 Phoenix-Mesa SIP Submittal and 2020 Yuma SIP Submittal each document the public review process followed prior to their submittal to the EPA as revisions to the SIP.</P>
                <P>
                    Appendix B of the 2020 Phoenix-Mesa SIP Submittal includes documentation of notices of opportunity for public hearing and comment on the SIP submittal. The notices for opportunity for public hearing and comment on the SIP submittal were posted in 
                    <E T="03">The Arizona Republic,</E>
                     sent by email to interested parties, and posted on MAG's website. Also included in Appendix B of the 2020 Phoenix-Mesa SIP Submittal is a responsiveness summary indicating that no comments or requests for public hearing were received during the 30-day public review period.
                </P>
                <P>
                    Appendix B of the 2020 Yuma SIP Submittal includes documentation of a notice of public comment period and hearing on the SIP submittal posted in 
                    <E T="03">The Arizona Republic</E>
                     on October 9, 2020, and October 10, 2020. Appendix B of the 2020 Yuma SIP Submittal also contains documentation of the November 12, 2020 public hearing on the SIP submittal including a sign-in sheet, transcript, signed certification that the public hearing was held, and a compilation of comments received and ADEQ's responses to comments.
                </P>
                <HD SOURCE="HD1">II. Arizona's Emissions Inventories</HD>
                <P>
                    The 2020 Phoenix-Mesa SIP Submittal and 2020 Yuma SIP Submittal each address the emissions inventory requirement in CAA section 182(a)(1). Each submittal provides documentation of a 2017 base year inventory of emissions of NO
                    <E T="52">X</E>
                     and VOC. The 2017 base year emissions inventory was the most recent triennial emissions inventory in the National Emissions Inventory (NEI) at the time the emissions inventories were prepared for the Phoenix-Mesa and Yuma areas.
                </P>
                <P>
                    Each emissions inventory submittal includes emissions estimates for the following source categories: Point sources, nonpoint sources, nonroad mobile sources, onroad mobile sources, and biogenic sources. Point sources are generally large, stationary (
                    <E T="03">i.e.,</E>
                     non-mobile) sources of air pollutants. MAG's and ADEQ's specific interpretations of the point source definition are described in sections II.A and II.B of this notice, respectively. Nonpoint sources, also referred to as “area” sources, are the sources of air pollutants that are typically too small or too numerous to be categorized as point or mobile sources, such as residential combustion or consumer products. Nonroad mobile sources, also referred to as “off-highway” mobile sources, include nonroad engines and nonroad vehicles. Onroad mobile sources, also referred to as “highway mobile sources,” are motor vehicles traveling on local highways and roads. Biogenic sources emit pollutants produced by natural sources including vegetation and soils.
                </P>
                <P>
                    ADEQ and MAG each used a combination of top-down estimation techniques (
                    <E T="03">i.e.,</E>
                     allocation of regional emissions estimates to a smaller, defined geographic area) and bottom-up estimation techniques (
                    <E T="03">i.e.,</E>
                     development of source or source category emissions estimates using emissions factors, models, etc.) to develop the emissions inventories in their respective SIP submittals. Specific estimation techniques for each source category are described in sections II.A and II.B of this notice.
                </P>
                <HD SOURCE="HD2">A. Baseline Emissions Inventory for the Phoenix-Mesa Nonattainment Area</HD>
                <P>
                    The emissions inventory included in the 2020 Phoenix-Mesa SIP Submittal was developed by MAG. The Phoenix-Mesa area includes Maricopa County and portions of Gila and Pinal Counties.
                    <SU>9</SU>
                    <FTREF/>
                     MAG selected the months of June through August to estimate ozone season day emissions of NO
                    <E T="52">X</E>
                     and VOC from sources in the Phoenix-Mesa area.
                    <SU>10</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         See 83 FR 25776, 25784-25785, for a detailed description of the boundaries of the Phoenix-Mesa nonattainment area for the 2015 ozone NAAQS.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         A detailed justification for MAG's selection of months in the ozone season is provided in Appendix F of the 2020 Phoenix-Mesa SIP Submittal.
                    </P>
                </FTNT>
                <P>
                    In the 2020 Phoenix-Mesa SIP Submittal, MAG defines point sources consistent with the point source definition put forth in EPA's air emissions reporting requirements (AERR).
                    <SU>11</SU>
                    <FTREF/>
                     MAG identified 19 stationary sources meeting the point source definition in the Phoenix-Mesa area. As noted in the 2020 Phoenix-Mesa SIP Submittal, while some stationary sources in Maricopa County are permitted by ADEQ, no ADEQ-permitted facilities meet the point source definition, and such sources are instead categorized as area sources. All point sources in the Phoenix-Mesa area are located in Maricopa County and are permitted by the Maricopa County Air Quality District (MCAQD). MAG identified point sources in the Phoenix-Mesa area via the MCAQD electronic permit system database. MAG calculated emissions from point sources using annual source emissions reports, MCAQD investigation reports, permit files and logs, or telephone contacts with sources. Point source emissions calculations in the Phoenix-Mesa area also considered “rule effectiveness,” a factor that may be applied to emissions inventory estimates to account for regulatory programs which may be less than 100 percent effective.
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         Under the AERR, a point source is a facility that is a major source under 40 CFR part 70 for one or more of the pollutants for which reporting is required by CAA section 51.15(a)(1), but not with regard to emissions of hazardous air pollutants. 80 FR 8787 (February 19, 2015). For major source emissions thresholds by pollutant, see 40 CFR 51.30.
                    </P>
                </FTNT>
                <P>
                    In the point source category, MAG also accounted for actual and potential voluntary emissions reductions at point sources in the Phoenix-Mesa area. Major new sources and major modifications in the Phoenix-Mesa area must offset the emissions of NO
                    <E T="52">X</E>
                     and VOC generated by the new source or modification as a condition for approval of permit applications. These emissions offsets are generally obtained from existing sources located in the vicinity of the proposed source or modification in the form of emissions reduction credits (ERCs). The rules governing the generation and use of ERCs in the Phoenix-Mesa area area are outlined in MCAQD Rule 240. In the 2017 base year inventory, MAG included certified ERCs available in the Arizona Emissions Bank in the point source category totals. MAG also included potential (
                    <E T="03">i.e.,</E>
                     not yet certified) sources of ERCs for NO
                    <E T="52">X</E>
                     and VOC in the 
                    <PRTPAGE P="58633"/>
                    base year inventory in order to maintain the availability of these emissions in the periodic inventory, provided that sufficient documentation can be secured to confirm the emissions reductions in the future.
                </P>
                <P>MAG estimated county-level emissions from nonpoint sources using a variety of tools, techniques, and assumptions depending on each nonpoint source subcategory. MAG's nonpoint source emissions estimates were informed by EPA's 2017 nonpoint emissions methodology and operator instructions, source-submitted annual emissions reports, and scaling up via the use of per-employee emissions factors. For each nonpoint source subcategory, county-level emissions estimates were allocated to the Phoenix-Mesa area using one of five representative variables: Employment, population, land use, general aviation operations, and location data. Each nonpoint source emissions calculation and allocation method is described in detail in the 2020 Phoenix-Mesa SIP Submittal.</P>
                <P>
                    Nonroad mobile source subcategories in the Phoenix-Mesa emissions inventory include agricultural equipment (
                    <E T="03">e.g.,</E>
                     tractors, combines, and balers), recreational equipment (
                    <E T="03">e.g.,</E>
                     all-terrain vehicles and off-road motorcycles), aircraft, and locomotives, among others. For most nonroad mobile source subcategories, MAG estimated emissions using the latest available version of EPA's Motor Vehicle Emission Simulator (MOVES2014b). Inputs to MOVES2014b included default model input files, National Oceanic and Atmospheric Administration (NOAA) National Centers for Environmental Information (NCEI) local climatological data, 2017 fuel specifications and vapor recovery program effectiveness from the Arizona Department of Agriculture Weights &amp; Measures Services Division, and local data from a 2003 survey performed for ADEQ by ENVIRON. For aircraft and airport equipment, MAG estimated emissions using the Federal Aviation Administration (FAA) Aviation Environmental Design Tool version 2d (AEDT 2d). Inputs to AEDT 2d included local aircraft activity data from the FAA Operations Network, 
                    <E T="03">AirNav.com</E>
                    , and base personnel at Luke Air Force Base. Additionally, MAG utilized aircraft fleet mix profiles from the FAA Traffic Flow Management System Counts database, verification of AirNav.com data using the FAA 5010 Airport Master Records database, and general aviation airport survey data conducted by MAG in 2017. Emissions from locomotives were estimated using survey data from the three railroad companies operating in Maricopa County (
                    <E T="03">i.e.,</E>
                     Burlington Northern Santa Fe, Union Pacific, and Amtrak) and emissions factors published by ENVIRON and the EPA.
                </P>
                <P>Emissions from onroad mobile sources in the Phoenix-Mesa area were calculated using MOVES2014b. For onroad mobile sources, MOVES2014b requires local data inputs relating to vehicle inspection and maintenance programs, meteorological data, vehicle populations, source type age distributions, annual vehicle miles traveled, and alternative vehicle and fuel technologies, among others. MAG cited numerous sources and assumptions for local data inputs, including vehicle registration data from the Arizona Department of Transportation, meteorological data from the NOAA NCEI, and the MAG Transportation Modeling Group.</P>
                <P>Emissions from biogenic sources in the Phoenix-Mesa area were calculated using the Model of Emissions of Gases and Aerosols from Nature (MEGAN) version 2.1. MEGAN requires inputs of land cover and meteorological data. MAG utilized 1-kilometer eight-day average leaf area index from the National Aeronautics and Space Administration's Moderate Resolution Imaging Spectroradiometer satellite observations, plant functional type (PFT) data from the National Land Cover Dataset, and emission factors derived from PFT distributions. MAG processed meteorological data from the Weather Research and Forecasting model version 3.9 with the Meteorology-Chemistry Interface Processor (MCIP). The model outputs from MCIP were further processed using the MEGAN component program called MET2MGN for input to MEGAN.</P>
                <P>MAG employed quality assurance and quality control (QA/QC) measures throughout the development of the Phoenix-Mesa emissions inventory. Point source emissions reports undergo automated QA/QC upon submission to MCAQD's database as well as manual QA/QC performed by air quality planning staff. Area source emissions calculations are peer-reviewed by air quality planners to ensure calculations can be reproduced. Other QA/QC procedures performed by MAG include review of files by personnel not involved in the development of the inventory as well as comparison of the 2017 inventory to 2014 and 2011 inventories. MAG's QA/QC procedures are described in detail in the 2020 Phoenix-Mesa SIP submittal.</P>
                <P>
                    Estimates of 2017 ozone season day emissions of NO
                    <E T="52">X</E>
                     and VOC in the Phoenix-Mesa area are summarized in Table 1 below.
                </P>
                <GPOTABLE COLS="7" OPTS="L2,i1" CDEF="s50,12,12,12,12,12,12">
                    <TTITLE>Table 1—2017 Ozone Season Day Emissions</TTITLE>
                    <TTITLE>Phoenix-Mesa Ozone Nonattainment Area</TTITLE>
                    <BOXHD>
                        <CHED H="1">Pollutant</CHED>
                        <CHED H="1">
                            Ozone season day emissions
                            <LI>(pounds per day)</LI>
                        </CHED>
                        <CHED H="2">Point</CHED>
                        <CHED H="2">Nonpoint</CHED>
                        <CHED H="2">
                            Nonroad
                            <LI>mobile</LI>
                        </CHED>
                        <CHED H="2">
                            Onroad
                            <LI>mobile</LI>
                        </CHED>
                        <CHED H="2">Biogenic</CHED>
                        <CHED H="2">Area total</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">
                            NO
                            <E T="0732">X</E>
                        </ENT>
                        <ENT>24,277</ENT>
                        <ENT>32,880</ENT>
                        <ENT>112,100</ENT>
                        <ENT>140,154</ENT>
                        <ENT>5,896</ENT>
                        <ENT>315,307</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">VOC</ENT>
                        <ENT>8,625</ENT>
                        <ENT>209,885</ENT>
                        <ENT>63,661</ENT>
                        <ENT>112,746</ENT>
                        <ENT>1,283,539</ENT>
                        <ENT>1,678,457</ENT>
                    </ROW>
                    <TNOTE>
                        <E T="02">Source:</E>
                         2020 Phoenix-Mesa SIP Submittal, Appendix A, 11.
                    </TNOTE>
                </GPOTABLE>
                <HD SOURCE="HD2">B. Baseline Emissions Inventory for the Yuma Nonattainment Area</HD>
                <P>
                    The emissions inventory included in the 2020 Yuma SIP Submittal was developed by ADEQ. The Yuma area consists of approximately 52 square miles within Yuma County in and around the city of Yuma, Arizona.
                    <SU>12</SU>
                    <FTREF/>
                     ADEQ selected the months of April through October to estimate ozone season day emissions of NO
                    <E T="52">X</E>
                     and VOC from sources in the Yuma area.
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         See 83 FR 25776, 25785 for a detailed description of the boundaries of the Yuma nonattainment area for the 2015 ozone NAAQS.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         ADEQ's selection of the months in the ozone season is consistent with documentation provided by ADEQ along with its initial nonattainment boundary recommendations for the 2015 ozone NAAQS. See the technical support document 
                        <PRTPAGE/>
                        “Phoenix-Mesa and Yuma Nonattainment Areas; Intended Area Designations for the 2015 Ozone National Ambient Air Quality Standards,” included in the docket for EPA's initial designations for the 2015 ozone NAAQS under docket ID EPA-HQ-OAR-2017-0548.
                    </P>
                </FTNT>
                <PRTPAGE P="58634"/>
                <P>ADEQ obtained emissions estimates for point sources in the Yuma area from the 2017 NEI and from source-submitted annual emissions inventory reports required for all sources holding a minor permit in Arizona. All point sources listed in the 2017 NEI and geographically located in the Yuma ozone nonattainment area were included in the point source category in the 2020 Yuma SIP Submittal. ADEQ also included minor point sources holding permits in the Yuma ozone nonattainment area in the point source category.</P>
                <P>Emissions from Yuma area nonpoint sources (also referred to as “area sources” in the 2020 Yuma SIP Submittal) were estimated predominantly using data from the 2017 NEI. The 2017 NEI includes emissions estimates for numerous area source subcategories on the county level. For most nonpoint source subcategories, ADEQ allocated county-level emissions estimates from the 2017 NEI to the Yuma area based on population, industrial employment, land area, crop land area, or railroad length. Emissions calculation methods used for the remaining nonpoint source subcategories include per-person emissions factors included in 2017 NEI documentation, information from permits, and information from source-submitted annual reports.</P>
                <P>ADEQ estimated emissions from nonroad mobile sources in the Yuma area by allocating emissions from 2017 NEI data using representative factors including population, cropland area, and railroad length. Nonroad mobile source categories addressed in the 2020 Yuma SIP submittal include: Agricultural equipment; commercial equipment; construction and mining equipment; industrial equipment; lawn and garden equipment; logging equipment; recreational equipment; pleasure craft; and locomotives. Of the eight private and public airports identified by ADEQ in Yuma County, none are located within the Yuma ozone nonattainment area. Therefore, ADEQ assumed zero nonroad mobile source emissions from airports.</P>
                <P>
                    Emissions from onroad mobile sources in the Yuma area were calculated using MOVES2014b. In the 2020 Yuma SIP Submittal, ADEQ listed MOVES2014b inputs for source type, road type, fuel type, and process type. ADEQ notes in the 2020 Yuma SIP Submittal that the Yuma area is located adjacent to a major trucking and travel corridor, and freight haulers and tractor trailers are primary producers of VOC and NO
                    <E T="52">X</E>
                     emissions in the Yuma area.
                </P>
                <P>ADEQ estimated emissions from biogenic sources in the Yuma area using biogenic emissions data from the 2017 NEI. County-level biogenic emissions from the 2017 NEI were allocated to the Yuma area using the ratio of land area in the Yuma ozone nonattainment area to the land area within Yuma County. As described in the 2020 Yuma SIP Submittal, ozone season day biogenic emissions were estimated by summing the biogenic emissions in the Yuma area for each month in the ozone season (April through October) and dividing by the number of days in the ozone season (213 days).</P>
                <P>
                    ADEQ engaged numerous QA/QC procedures in the development of the 2020 Yuma SIP Submittal. ADEQ prepared an inventory preparation plan (IPP) and incorporated feedback from the EPA on the IPP to identify and follow suitable estimation methodologies. Procedures outlined in ADEQ's EPA-reviewed quality assurance project plan were followed to conduct QA/QC on emissions estimates submitted by sources.
                    <SU>14</SU>
                    <FTREF/>
                     In general, ADEQ conducted peer and management review of the technical support document to the 2020 Yuma SIP Submittal and underlying calculations. A detailed description of ADEQ's QA/QC procedures is included in the 2020 Yuma SIP Submittal.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         ADEQ's “Annual Permitted Source Emissions Inventories Quality Assurance Project Plan” (October 2020) is included in the docket for this rulemaking.
                    </P>
                </FTNT>
                <P>The 2021 Yuma SIP Supplement provides clarification on emissions inventory details including selection of ozone season months, handling of seasonal emissions distribution, consideration of weekday emissions schedules, and ADEQ's QA/QC process. Based on input from the EPA regarding the consideration of weekday emissions schedules and of the ozone season in the Yuma nonattainment area, ADEQ made corrections to some of its ozone season day emissions estimates compared to the values provided in the original 2020 Yuma SIP Suibmittal. All changes to estimations of ozone season day emissions are described in detail in the 2021 Yuma SIP Supplement.</P>
                <P>
                    Estimates of 2017 ozone season day emissions of NO
                    <E T="52">X</E>
                     and VOC in the Yuma area are summarized in Table 2 below.
                </P>
                <GPOTABLE COLS="7" OPTS="L2,i1" CDEF="s50,12,12,12,12,12,12">
                    <TTITLE>Table 2—2017 Ozone Season Day Emissions</TTITLE>
                    <TTITLE>Yuma Ozone Nonattainment Area</TTITLE>
                    <BOXHD>
                        <CHED H="1">Pollutant</CHED>
                        <CHED H="1">
                            Ozone season day emissions
                            <LI>(pounds per day)</LI>
                        </CHED>
                        <CHED H="2">Point</CHED>
                        <CHED H="2">Nonpoint</CHED>
                        <CHED H="2">
                            Nonroad
                            <LI>mobile</LI>
                        </CHED>
                        <CHED H="2">Onroad mobile</CHED>
                        <CHED H="2">Biogenic</CHED>
                        <CHED H="2">Area total</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">
                            NO
                            <E T="0732">X</E>
                        </ENT>
                        <ENT>1,113</ENT>
                        <ENT>1,275</ENT>
                        <ENT>2,158</ENT>
                        <ENT>10,402</ENT>
                        <ENT>38</ENT>
                        <ENT>14,986</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">VOC</ENT>
                        <ENT>138</ENT>
                        <ENT>15,007</ENT>
                        <ENT>2,737</ENT>
                        <ENT>5,527</ENT>
                        <ENT>2,849</ENT>
                        <ENT>26,259</ENT>
                    </ROW>
                    <TNOTE>
                        <E T="02">Source:</E>
                         2021 Yuma SIP Supplement, 6.
                    </TNOTE>
                </GPOTABLE>
                <HD SOURCE="HD1">III. EPA's Evaluation</HD>
                <P>Based on the documentation included in Arizona's submittals, the EPA finds that the submittals satisfy the procedural requirements of sections 110(a)(1) and 110(l) of the Act requiring states to provide reasonable notice and an opportunity for public hearing prior to adoption of SIP revisions. The 2020 Phoenix-Mesa SIP Submittal became complete by operation of law on January 8, 2021, and the 2020 Yuma SIP Submittal became complete by operation of law on June 22, 2021, pursuant to section 110(k)(1)(B).</P>
                <P>
                    The EPA has reviewed Arizona's submittals for consistency with CAA sections 172(c)(3) and 182(a)(1) and the requirements for emissions inventories under the EPA's implementing regulations for the 2015 ozone NAAQS at 40 CFR 51.1315. The 2017 baseline emissions inventories represent the 
                    <PRTPAGE P="58635"/>
                    most recent calendar year for which a consistent and comprehensive statewide inventory was available. The selection of a 2017 baseline year for the Phoenix-Mesa and Yuma emissions inventories is therefore consistent with the requirement for selection of RFP baseline years under 40 CFR 51.1310(b). We find that the Phoenix-Mesa and Yuma emissions inventories appropriately estimated the average day's emissions for a typical weekday in the ozone season, consistent with the definition of ozone season day emissions under 40 CFR 51.1300(q).
                </P>
                <P>Arizona's submittals document the procedures used by MAG and ADEQ to estimate ozone season day emissions for each of the major source types. Documentation of emissions estimation procedures in the 2020 Phoenix-Mesa SIP Submittal and 2020 Yuma SIP Submittal demonstrate that MAG and ADEQ followed acceptable procedures to develop emissions estimates. The 2020 Phoenix-Mesa SIP Submittal and 2020 Yuma SIP Submittal each also describe the specific QA/QC measures implemented to ensure the accuracy and integrity of data throughout the development of each respective emissions inventory.</P>
                <P>
                    Based upon the documentation of emissions estimation techniques and QA/QC procedures employed to develop the emissions inventories in each submittal, we find that the 2020 Phoenix-Mesa SIP Submittal and 2020 Yuma SIP Submittal contain comprehensive, accurate, current inventories of actual emissions from all sources in the Phoenix-Mesa and Yuma ozone nonattainment areas, respectively. The EPA thereby proposes to approve the baseline inventories of NO
                    <E T="52">X</E>
                     and VOC emissions for the Phoenix-Mesa and Yuma ozone nonattainment areas for the 2015 ozone NAAQS submitted by Arizona pursuant to 40 CFR 51.1315 and CAA sections 172(c)(3) and 182(b)(1) .
                </P>
                <HD SOURCE="HD1">IV. Proposed Action and Request for Public Comment</HD>
                <P>We are proposing to approve the 2020 Phoenix-Mesa SIP Submittal and 2020 Yuma SIP Submittal as meeting the ozone-related baseline emissions inventory requirement for the Phoenix-Mesa and Yuma ozone nonattainment areas for the 2015 ozone NAAQS. The emissions inventories we are proposing to approve into the SIP are summarized in tables 1 and 2 of this notice. We are proposing to approve the emissions inventories because they contain comprehensive, accurate, and current inventories of actual emissions for all relevant sources in accordance with CAA sections 172(c)(3) and 182(a). The EPA is soliciting public comments on the issues discussed in this proposed rule. We will accept comments from the public on this proposal for the next 30 days.</P>
                <HD SOURCE="HD1">V. 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 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 proposed action merely proposes to approve state plans as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:</P>
                <P>• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 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);</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; and</P>
                <P>• Does not provide the EPA with the discretionary authority to address disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994).</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. The Fort McDowell Yavapai Nation, the Gila River Indian Community of the Gila River Indian Reservation, the Tohono O'odham Nation of Arizona, and the Salt River Pima Maricopa Indian Community of the Salt River Reservation have areas of Indian country located within the Phoenix-Mesa nonattainment area for the 2015 ozone NAAQS. The Cocopah Tribe of Arizona and the Quechan Tribe of the Fort Yuma Indian Reservation have areas of Indian country located within the Yuma nonattainment area for the 2015 ozone NAAQS. In those areas of Indian country, the proposed rule does not have tribal implications and 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>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 40 CFR Part 52</HD>
                    <P>Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.</P>
                </LSTSUB>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P>
                        42 U.S.C. 7401 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: October 9, 2021.</DATED>
                    <NAME>Deborah Jordan,</NAME>
                    <TITLE>Acting Regional Administrator, Region IX.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-22662 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </PRORULE>
    </PRORULES>
    <VOL>86</VOL>
    <NO>202</NO>
    <DATE>Friday, October 22, 2021</DATE>
    <UNITNAME>Notices</UNITNAME>
    <NOTICES>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="58636"/>
                <AGENCY TYPE="F">DEPARTMENT OF AGRICULTURE</AGENCY>
                <SUBJECT>Submission for OMB Review; Comment Request</SUBJECT>
                <DATE>October 19, 2021.</DATE>
                <P>The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding: Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; ways to enhance the quality, utility and clarity of the information to be collected; and ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.</P>
                <P>
                    Comments regarding this information collection received by November 22, 2021 will be considered. Written comments and recommendations for the proposed information collection should be submitted within 30 days of the publication of this notice on the following website 
                    <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                     Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
                </P>
                <P>An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.</P>
                <HD SOURCE="HD1">Risk Management Agency</HD>
                <P>
                    <E T="03">Title:</E>
                     Acreage/Crop Reporting Streamlining Initiative.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     0563-0084.
                </P>
                <P>
                    <E T="03">Summary of Collection:</E>
                     Section 508(f)(3) of the Federal Crop Insurance Act (7 U.S.C. 1515); 7 U.S.C. 7333(b)(3); 7 CFR 457.8 and 7 CFR 1437.7(d) mandates the collection of acreage and production information from producers who wish to participate in certain USDA programs. The Farm Service Agency (FSA) and the Risk Management Agency (RMA) are implementing the Acreage/Crop Reporting Streamlining Initiative (ACRSI), a web-based single source reporting system to establish a single reporting and data collection.
                </P>
                <P>
                    <E T="03">Need and use of the Information:</E>
                     This initiative is being conducted in phases by geographical area and additional commodities. Counties are selected based on their commonality of historical crop reporting, high percentage of producers participating in both RMA and FSA programs and the high level of interest of the private agricultural service industry (precision-ag and farm management) in the pilot phases. It will reengineer the procedures, processes, and standards to simplify commodity, acreage and production reporting by producers, eliminate or minimize duplication of information collection by multiple agencies and reduce the burden on producers, insurance agents and AIPs. Information being collected will consist of, but not be limited to: Producer name, location state, commodity name, commodity type or variety, location county, date planted, land location (legal description, FSA farm number, FSA track number, FSA field number), intended use, prevented planting acres, acres planted but failed, planted acres, and production of commodity produced. Failure to collect the applicable information could result in unearned Federal benefits being issued or producers being denied eligibility to program benefits.
                </P>
                <P>
                    <E T="03">Description of Respondents:</E>
                     Individuals and households.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     500,000.
                </P>
                <P>
                    <E T="03">Frequency of Responses:</E>
                     Reporting: One time.
                </P>
                <P>
                    <E T="03">Total Burden Hours:</E>
                     187,500.
                </P>
                <SIG>
                    <NAME>Levi S. Harrell,</NAME>
                    <TITLE>Departmental Information Clearance Officer.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23061 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3410-08-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBJECT>Membership of the Performance Review Board for the Office of the Secretary</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of the Secretary, Department of Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of membership on the Office of the Secretary Performance Review Board.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Office of the Secretary, the Department of Commerce (DOC), announces the appointment of those individuals who have been selected to serve as members of the Performance Review Board. The Performance Review Board is responsible for reviewing performance appraisals and ratings of Senior Executive Service (SES) members and Senior Level (SL) members and making recommendations to the appointing authority on other performance management issues, such as pay adjustments, bonuses and Presidential Rank Awards. The appointment of these members to the Performance Review Board will be for a period of twenty-four (24) months.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The period of appointment for those individuals selected for the Office of the Secretary Performance Review Board begins on October 22, 2021.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Christine Covington, U.S. Department of Commerce, Office of Human Resources Management, Office of Executive Resources, 14th and Constitution Avenue NW, Room 50013, Washington, DC 20230, at (202) 482-2613.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    In accordance with 5 U.S.C. 4314 (c) (4), the Office of the Secretary, Department of Commerce (DOC), announces the appointment of those individuals who have been selected to serve as members of the Office of the Secretary Performance Review Board. The Performance Review Board is responsible for (1) reviewing performance appraisals and ratings of Senior Executive Service (SES) and (SL) members and (2) making recommendations to the appointing 
                    <PRTPAGE P="58637"/>
                    authority on other performance management issues, such as pay adjustments, bonuses and Presidential Rank Awards. The appointment of these members to the Performance Review Board will be for a period of twenty-four (24) months.
                </P>
                <P>The name, position title, and type of appointment of each member of the Performance Review Board are set forth below:</P>
                <EXTRACT>
                    <FP SOURCE="FP-2">1. Olivia Bradley, Deputy for Procurement Management, Policy and Performance Excellence, OS Career SES</FP>
                    <FP SOURCE="FP-2">2. Stephanie Sykes, Director of Intergovernmental Affairs, OS Non-Career SES</FP>
                    <FP SOURCE="FP-2">3. Terri Ware, Deputy Chief Information Officer for Policy and Business Management, OS Career SES</FP>
                    <FP SOURCE="FP-2">4. John Guenther, Associate Deputy General Counsel, OS, Career SES</FP>
                    <FP SOURCE="FP-2">5. Alex Villanueva, Senior Director, ITA, Career SES</FP>
                    <FP SOURCE="FP-2">6. Teresa Coppolino, Director, Financial Management Systems, OS, Career SES</FP>
                    <FP SOURCE="FP-2">7. Brian DiGiacomo, Assistant General Counsel for Employment, Litigation, and Information Law, OGC, Career SES</FP>
                    <FP SOURCE="FP-2">8. Cynthia Aragon Deputy Assistant Secretary for Industry and Analysis, ITA, Non-Career SES</FP>
                    <FP SOURCE="FP-2">9. Kevin Kurland, Deputy Assistant Secretary for Export Enforcement, BIS, Career SES</FP>
                    <FP SOURCE="FP-2">10. Jon Alexander, Deputy Director, Office of Financial Management, OS Career SES</FP>
                    <FP SOURCE="FP-2">11. Melissa Skinner, Senior Director, AD/CVD Enforcement Office VII, ITA Career SES</FP>
                    <FP SOURCE="FP-2">12. Scot Fullerton, Association Deputy Assistant Secretary for AD/VDC Operations, ITA Career SES</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>Christine Covington,</NAME>
                    <TITLE>Human Resources Specialist, Office of Executive Resources, Office of Human Resources Management.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23055 Filed 10-21-21; 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>
                <SUBJECT>Membership of the International Trade Administration Performance Review Board</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>International Trade Administration, Department of Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of Membership on the International Trade Administration's Performance Review Board.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The International Trade Administration (ITA), Department of Commerce (DOC), announces the appointment of those individuals who have been selected to serve as members of ITA's Performance Review Board. The Performance Review Board is responsible for (1) reviewing performance appraisals and ratings of Senior Executive Service (SES) members and (2) making recommendations to the appointing authority on other performance management issues, such as pay adjustments, bonuses and Presidential Rank Awards for SES. The appointment of these members to the Performance Review Board will be for a period of twenty-four (24) months.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The period of appointment for those individuals selected for ITA's Performance Review Board begins on October 22, 2021.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Christine Covington, U.S. Department of Commerce, Office of Human Resources Management, Office of Executive Resources, 14th and Constitution Avenue NW, Room 50013, Washington, DC 20230, at (202) 482-2613.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>In accordance with 5 U.S.C. 4314(c)(4), the International Trade Administration (ITA), Department of Commerce (DOC), announces the appointment of those individuals who have been selected to serve as members of the ITA Performance Review Board. The Performance Review Board is responsible for (1) reviewing performance appraisals and ratings of Senior Executive Service (SES) members and (2) making recommendations to the appointing authority on other Performance management issues, such as pay adjustments, bonuses and Presidential Rank Awards for SES. The Appointment of these members to the Performance Review Board will be for a period of twenty-four (24) months. The name, position title, and type of appointment of each member of the Performance Review Board are set forth below:</P>
                <EXTRACT>
                    <FP SOURCE="FP-2">1. Monica Gorman, Deputy Assistant Secretary for Manufacturing, Non-Career SES</FP>
                    <FP SOURCE="FP-2">2. James Maeder, Deputy Assistant Secretary for Enforcement and Compliance, Career SES</FP>
                    <FP SOURCE="FP-2">3. Anne Driscoll, Deputy Assistant Secretary for Industry and Analysis, Career SES</FP>
                    <FP SOURCE="FP-2">4. Praveen Dixit, Deputy Assistant Secretary for Trade Policy and Analysis, Career SES</FP>
                    <FP SOURCE="FP-2">5. Rona Bunn, Chief Information Officer, Career SES</FP>
                    <FP SOURCE="FP-2">6. Kurt Bersani, Chief Financial Officer and Director of Administration, OS Enterprise Services, Career SES</FP>
                    <FP SOURCE="FP-2">7. Steven Presing, Executive Director for Anti-Dumping and Subsidies Policy and Negotiation Career SES</FP>
                    <FP SOURCE="FP-2">8. Catrina Purvis, Chief Information Officer and Deputy Director for Policy Coordination and Management NTIA, Career SES</FP>
                    <FP SOURCE="FP-2">9. David DaFalco, Deputy Assistant Secretary for Europe, Career SES</FP>
                    <FP SOURCE="FP-2">10. Ian Saunders, DAS for Western Hemisphere, Career SES</FP>
                    <FP SOURCE="FP-2">11. Cara Morrow, Director of Policy, Non-Career SES</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>Christine Covington,</NAME>
                    <TITLE>Human Resources Specialist, Office of Executive Resources, Office of Human Resources Management.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23046 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-DS-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBJECT>Membership of the Performance Review Board for EDA, NTIA, BIS and MBDA</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Economic Development Administration (EDA), National Telecommunications and Information Administration (NTIA), Bureau of Industry and Security (BIS), Minority Business Development Agency (MBDA), Department of Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of membership on the EDA, NTIA, BIS and MBDA's Performance Review Board.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The EDA, NTIA, BIS and MBDA, Department of Commerce (DOC), announce the appointment of those individuals who have been selected to serve as members of the Performance Review Board. The Performance Review Board is responsible for reviewing performance appraisals and ratings of Senior Executive Service (SES) members and Senior Level (SL) members and making recommendations to the appointing authority on other performance management issues, such as pay adjustments, bonuses and Presidential Rank Awards for SES and SL members. The appointment of these members to the Performance Review Board will be for a period of twenty-four (24) months.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The period of appointment for those individuals selected for EDA, NTIA, BIS and MBDA's Performance Review Board begins on October 22, 2021.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Christine Covington, U.S. Department of Commerce, Office of Human Resources Management, Office of Executive Resources, 14th and Constitution Avenue NW, Room 50013, Washington, DC 20230, at (202) 482-2613.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    In accordance with 5 U.S.C. 4314(c)(4), the EDA, NTIA, BIS, and MBDA, Department of Commerce (DOC), announce the appointment of those individuals who have been selected to 
                    <PRTPAGE P="58638"/>
                    serve as members of EDA, NTIA, BIS and MBDA's Performance Review Board. The Performance Review Board is responsible for (1) reviewing performance appraisals and ratings of Senior Executive Service (SES) and Senior Level (SL) members and (2) making recommendations to the appointing authority on other Performance management issues, such as pay adjustments, bonuses and Presidential Rank Awards for SES and SL members. The Appointment of these members to the Performance Review Board will be for a period of twenty-four (24) months:
                </P>
                <P>The name, position title, and type of appointment of each member of the Performance Review Board are set forth below:</P>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        1. 
                        <E T="03">Department of Commerce, Bureau of Industry and Security (BIS),</E>
                         Matthew Borman Deputy Assistant Secretary for Export Administration, Career SES
                    </FP>
                    <FP SOURCE="FP-2">
                        2. 
                        <E T="03">Department of Commerce, National Telecommunications and Information Administration (NTIA),</E>
                         Margaret Mitchell, Chief Financial Officer and Director of Administration, Career SES
                    </FP>
                    <FP SOURCE="FP-2">
                        3. 
                        <E T="03">Department of Commerce, Economic Development Agency (EDA),</E>
                         Michele Chang, Deputy Assistant Secretary for Policy, Non-Career SES
                    </FP>
                    <FP SOURCE="FP-2">
                        4. 
                        <E T="03">Department of Commerce, National Telecommunications and Information Administration (NTIA),</E>
                         Scott Palmer, Chief Procurement Officer, First Responder Network Authority, Career SES
                    </FP>
                    <FP SOURCE="FP-2">
                        5. 
                        <E T="03">Department of Commerce, Minority Business Development Agency (MBDA),</E>
                         Edith McCloud, Associate Director for Management, Career SES
                    </FP>
                    <FP SOURCE="FP-2">
                        6. 
                        <E T="03">Department of Commerce, Office of the Secretary (OS),</E>
                         Laura O'Neil, Director, Office of Public Engagement, Non-Career SES
                    </FP>
                    <FP SOURCE="FP-2">
                        7. 
                        <E T="03">Department of Commerce, Bureau of Industry and Security (BIS),</E>
                         Eileen Albanese, Director Office of National Security and Technology Transfer Controls, Career SES
                    </FP>
                    <FP SOURCE="FP-2">
                        8. 
                        <E T="03">Department of Commerce, Bureau of Industry and Security (BIS),</E>
                         John Sonderman, Director, Office of Export Enforcement, Career SES 
                    </FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>Christine Covington,</NAME>
                    <TITLE>Human Resources Specialist, Office of Executive Resources, Office of Human Resources Management.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23053 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-DS-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>Bureau of Economic Analysis</SUBAGY>
                <SUBJECT>Bureau of Economic Analysis Advisory Committee Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Economic Analysis, U.S. Department of Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of public meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Pursuant to the Federal Advisory Committee Act, the Bureau of Economic Analysis (BEA) announces a meeting of the Bureau of Economic Analysis Advisory Committee. The meeting will address proposed improvements, extensions, and research related to BEA's economic accounts. In addition, the meeting will include an update on recent statistical developments.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Friday, November 19, 2021. The meeting begins at 10:00 a.m. and adjourns at 2:30 p.m.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>The safety and well-being of the public, committee members, and our staff is our top priority. In light of travel restrictions and social-distancing requirements due to COVID-19, this meeting will be held virtually.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Gianna Marrone, Program Analyst, U.S. Department of Commerce, Bureau of Economic Analysis, Suitland, MD 20746; phone (301) 278-9282.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The Committee was established September 2, 1999. The Committee advises the Director of BEA on matters related to the development and improvement of BEA's national, regional, industry, and international economic accounts, with a focus on new and rapidly growing areas of the U.S. economy. The committee provides recommendations from the perspectives of the economics profession, business, and government.</P>
                <P>
                    This meeting is open to the public. Anyone planning to attend the meeting must contact Gianna Marrone at BEA (301) 278-9282 or 
                    <E T="03">gianna.marrone@bea.gov.</E>
                     The call-in number, access code, and presentation link will be posted 24 hours prior to the meeting on 
                    <E T="03">https://www.bea.gov/about/bea-advisory-committee.</E>
                     The meeting is accessible to people with disabilities. Requests for foreign language interpretation or other auxiliary aids should be directed to Gianna Marrone at (301) 278-9282 by November 12, 2021.
                </P>
                <SIG>
                    <DATED>Dated: October 7, 2021.</DATED>
                    <NAME>Ryan Noonan,</NAME>
                    <TITLE>Designated Federal Officer, Bureau of Economic Analysis.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23018 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-06-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>Bureau of Economic Analysis</SUBAGY>
                <SUBJECT>Federal Economic Statistics Advisory Committee Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Economic Analysis, U.S. Department of Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of public meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Bureau of Economic Analysis (BEA) is giving notice of a meeting of the Federal Economic Statistics Advisory Committee (FESAC). The Committee advises the Under Secretary for Economic Affairs, the Directors of the Bureau of Economic Analysis and the Census Bureau, and the Commissioner of the U.S. Department of Labor's Bureau of Labor Statistics (BLS) on statistical methodology and other technical matters related to the collection, tabulation, and analysis of federal economic statistics. Email Gianna Marrone, 
                        <E T="03">gianna.marrone@bea.gov,</E>
                         by December 3, 2021, to attend. An agenda will be accessible prior to the meeting at 
                        <E T="03">https://apps.bea.gov/fesac/.</E>
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>December 10, 2021. The meeting begins at approximately 9 a.m. and adjourns at approximately 3:15 p.m.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>The safety and well-being of the public, committee members, and our staff is our top priority. In light of travel restrictions and social-distancing requirements due to COVID-19, this meeting will be held virtually.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Gianna Marrone, Program Analyst, U.S. Department of Commerce, Bureau of Economic Analysis, 4600 Silver Hill Road (BE-64), Suitland, MD 20746; phone (301) 278-9282; email 
                        <E T="03">gianna.marrone@bea.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>FESAC members are appointed by the Secretary of Commerce. The Committee advises the Under Secretary for Economic Affairs, BEA and Census Bureau Directors, and the Commissioner of the Department of Labor's BLS on statistical methodology and other technical matters related to the collection, tabulation, and analysis of federal economic statistics. The Committee is established in accordance with the Federal Advisory Committee Act (5 U.S.C. App. § 2).</P>
                <P>
                    This meeting is open to the public. Anyone planning to attend the meeting may contact Gianna Marrone at BEA (301) 278-9282 or 
                    <E T="03">gianna.marrone@bea.gov.</E>
                     The call-in number, access code, and presentation link will be posted 24 hours prior to the meeting on 
                    <E T="03">https://apps.bea.gov/fesac/.</E>
                     The meeting is accessible to people with 
                    <PRTPAGE P="58639"/>
                    disabilities. Requests for foreign language interpretation or other auxiliary aids should be directed to Gianna Marrone at 
                    <E T="03">gianna.marrone@bea.gov</E>
                     by December 3, 2021.
                </P>
                <P>
                    Persons with extensive questions or statements must submit them in writing by December 3, 2021, to Gianna Marrone, 
                    <E T="03">gianna.marrone@bea.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: October 18, 2021.</DATED>
                    <NAME>Sabrina Montes,</NAME>
                    <TITLE>Designated Federal Officer, Bureau of Economic Analysis.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23019 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-06-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>Economic Development Administration</SUBAGY>
                <SUBJECT>Notice of Petitions by Firms for Determination of Eligibility To Apply for Trade Adjustment Assistance</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Economic Development Administration, U.S. Department of Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice and opportunity for public comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Economic Development Administration (EDA) has received petitions for certification of eligibility to apply for Trade Adjustment Assistance from the firms listed below. Accordingly, EDA has initiated investigations to determine whether increased imports into the United States of articles like or directly competitive with those produced by each of the firms contributed importantly to the total or partial separation of the firms' workers, or threat thereof, and to a decrease in sales or production of each petitioning firm.</P>
                </SUM>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <GPOTABLE COLS="4" OPTS="L2,nj,i1" CDEF="s50,r50,12,r50">
                    <TTITLE>List of Petitions Received by EDA for Certification of Eligibility To Apply for Trade Adjustment Assistance</TTITLE>
                    <TDESC>[10/5/2021 through 10/14/2021]</TDESC>
                    <BOXHD>
                        <CHED H="1">Firm name</CHED>
                        <CHED H="1">Firm address</CHED>
                        <CHED H="1">
                            Date
                            <LI>accepted for</LI>
                            <LI>investigation</LI>
                        </CHED>
                        <CHED H="1">Product(s)</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">International Sensor Systems, Inc</ENT>
                        <ENT>103 Grant Street, Aurora, NE 68818</ENT>
                        <ENT>10/12/2021</ENT>
                        <ENT>The firm manufactures circuit boards.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Nova-Tech, Inc</ENT>
                        <ENT>4705 Gold Core Drive, Grand Island, NE 68801</ENT>
                        <ENT>10/14/2021</ENT>
                        <ENT>The firm manufactures pharmaceuticals for veterinary use.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>Any party having a substantial interest in these proceedings may request a public hearing on the matter. A written request for a hearing must be submitted to the Trade Adjustment Assistance Division, Room 71030, Economic Development Administration, U.S. Department of Commerce, Washington, DC 20230, no later than ten (10) calendar days following publication of this notice. These petitions are received pursuant to section 251 of the Trade Act of 1974, as amended.</P>
                <P>Please follow the requirements set forth in EDA's regulations at 13 CFR 315.8 for procedures to request a public hearing. The Catalog of Federal Domestic Assistance official number and title for the program under which these petitions are submitted is 11.313, Trade Adjustment Assistance for Firms.</P>
                <SIG>
                    <NAME>Bryan Borlik,</NAME>
                    <TITLE>Director.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23017 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-WH-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>International Trade Administration</SUBAGY>
                <SUBJECT>Quarterly Update to Annual Listing of Foreign Government Subsidies on Articles of Cheese Subject to an In-Quota Rate of Duty</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Enforcement and Compliance, International Trade Administration Department of Commerce.</P>
                </AGY>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicable October 22, 2021</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>John Hoffner, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Ave. NW, Washington, DC 20230, telephone: (202) 482-3315.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    On July 19, 2021, the Department of Commerce (Commerce), pursuant to section 702(h) of the Trade Agreements Act of 1979 (as amended) (the Act), published the quarterly update to the annual listing of foreign government subsidies on articles of cheese subject to an in-quota rate of duty covering the period January 1, 2021, through March 31, 2021.
                    <SU>1</SU>
                    <FTREF/>
                     In the 
                    <E T="03">First Quarter 2021 Update,</E>
                     we requested that any party that has information on foreign government subsidy programs that benefit articles of cheese subject to an in-quota rate of duty submit such information to Commerce.
                    <SU>2</SU>
                    <FTREF/>
                     We received no comments, information or requests for consultation from any party.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See Quarterly Update to Annual Listing of Foreign Government Subsidies on Articles of Cheese Subject to an In-Quota Rate of Duty,</E>
                         86 FR 38010 (July 19, 2021) (
                        <E T="03">First Quarter 2021 Update</E>
                        ).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>Pursuant to section 702(h) of the Act, we hereby provide Commerce's update of subsidies on articles of cheese that were imported during the period April 1, 2021, through June 30, 2021. The appendix to this notice lists the country, the subsidy program or programs, and the gross and net amounts of each subsidy for which information is currently available.</P>
                <P>
                    Commerce will incorporate additional programs which are found to constitute subsidies, and additional information on the subsidy programs listed, as the information is developed. Commerce encourages any person having information on foreign government subsidy programs which benefit articles of cheese subject to an in-quota rate of duty to submit such information in writing through the Federal eRulemaking Portal at 
                    <E T="03">http://www.regulations.gov,</E>
                     Docket No. ITA-2020-0005, “Quarterly Update to Cheese Subject to an In-Quota Rate of Duty.” The materials in the docket will not be edited to remove identifying or contact information, and Commerce cautions against including any information in an electronic submission that the submitter does not want publicly disclosed. Attachments to electronic comments will be accepted in Microsoft Word, Excel, or Adobe PDF formats only. All comments should be addressed to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, 1401 Constitution Ave. NW, Washington, DC 20230.
                </P>
                <P>This determination and notice are in accordance with section 702(a) of the Act.</P>
                <SIG>
                    <PRTPAGE P="58640"/>
                    <DATED>Dated: October 18, 2021.</DATED>
                    <NAME>Ryan Majerus,</NAME>
                    <TITLE>Deputy Assistant Secretary for Policy and Negotiations performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance.</TITLE>
                </SIG>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,r50,12,12">
                    <TTITLE>Appendix—Subsidy Programs on Cheese Subject to an In-Quota Rate of Duty</TTITLE>
                    <BOXHD>
                        <CHED H="1">Country</CHED>
                        <CHED H="1">Program(s)</CHED>
                        <CHED H="1">
                            Gross 
                            <SU>3</SU>
                            <LI>subsidy</LI>
                            <LI>($/lb)</LI>
                        </CHED>
                        <CHED H="1">
                            Net 
                            <SU>4</SU>
                             subsidy
                            <LI>($/lb)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">
                            27 European Union Member States 
                            <SU>5</SU>
                        </ENT>
                        <ENT>European Union Restitution Payments</ENT>
                        <ENT>0.00</ENT>
                        <ENT>0.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Canada</ENT>
                        <ENT>Export Assistance on Certain Types of Cheese</ENT>
                        <ENT>0.43</ENT>
                        <ENT>0.43</ENT>
                    </ROW>
                    <ROW RUL="n,n,s">
                        <ENT I="01">Norway</ENT>
                        <ENT>
                            Indirect (Milk) Subsidy
                            <LI>Consumer Subsidy</LI>
                        </ENT>
                        <ENT>0.00</ENT>
                        <ENT>0.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>  Total</ENT>
                        <ENT>0.00</ENT>
                        <ENT>0.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Switzerland</ENT>
                        <ENT>Deficiency Payments</ENT>
                        <ENT>0.00</ENT>
                        <ENT>0.00</ENT>
                    </ROW>
                </GPOTABLE>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23077 Filed 10-21-21; 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>
                <SUBJECT>Civil Nuclear Trade Advisory Committee; Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>International Trade Administration, U.S. Department of Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of an open meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice sets forth the schedule and proposed topics for a meeting of the Civil Nuclear Trade Advisory Committee (CINTAC).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        The meeting is scheduled for Thursday, November 4, 2021, from 11:00 a.m. to 12:30 p.m. Eastern Daylight Time (EDT). The deadline for members of the public to register to participate, including requests to make comments during the meeting and for auxiliary aids, or to submit written comments for dissemination prior to the meeting, is 5:00 p.m. EDT on Friday, October 29, 2021.
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>3</SU>
                             Defined in 19 U.S.C. 1677(5).
                        </P>
                        <P>
                            <SU>4</SU>
                             Defined in 19 U.S.C. 1677(6).
                        </P>
                        <P>
                            <SU>5</SU>
                             The 27 member states of the European Union are: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden.
                        </P>
                    </FTNT>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The meeting will be held virtually via Microsoft Teams. Requests to register to participate (including to speak or for auxiliary aids) and any written comments should be submitted via email to Mr. Jonathan Chesebro, Office of Energy &amp; Environmental Industries, International Trade Administration, at 
                        <E T="03">jonathan.chesebro@trade.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Mr. Jonathan Chesebro, Office of Energy &amp; Environmental Industries, International Trade Administration (Phone: 202-482-1297; email: 
                        <E T="03">jonathan.chesebro@trade.gov</E>
                        ).
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    <E T="03">Background:</E>
                     The CINTAC was established under the discretionary authority of the Secretary of Commerce and in accordance with the Federal Advisory Committee Act, as amended (5 U.S.C. App.), in response to an identified need for consensus advice from U.S. industry to the U.S. Government regarding the development and administration of programs to expand United States exports of civil nuclear goods and services in accordance with applicable U.S. laws and regulations, including advice on how U.S. civil nuclear goods and services export policies, programs, and activities will affect the U.S. civil nuclear industry's competitiveness and ability to participate in the international market.
                </P>
                <P>The Department of Commerce renewed the CINTAC charter on August 5, 2020. This meeting is being convened under the seventh charter of the CINTAC.</P>
                <P>On November 4, 2021, the CINTAC will hold the fourth meeting of its current charter term. The Committee, with officials from the U.S. Department of Commerce and other agencies, will discuss major issues affecting the competitiveness of the U.S. civil nuclear energy industry and discuss a proposed recommendation on U.S.-Canada civil nuclear cooperation. An agenda will be made available by October 29, 2021 upon request to Mr. Jonathan Chesebro.</P>
                <P>Members of the public wishing to attend the public session of the meeting must notify Mr. Chesebro at the contact information above by 5:00 p.m. EDT on Friday, October 29, 2021 in order to pre-register to participate. Please specify any requests for reasonable accommodation at least five business days in advance of the meeting. Last minute requests will be accepted but may not be possible to fill. A limited amount of time will be available for brief oral comments from members of the public attending the meeting. To accommodate as many speakers as possible, the time for public comments will be limited to two (2) minutes per person, with a total public comment period of 30 minutes. Individuals wishing to reserve speaking time during the meeting must contact Mr. Chesebro and submit a brief statement of the general nature of the comments and the name and address of the proposed participant by 5:00 p.m. EDT on Friday, October 29, 2021. If the number of registrants requesting to make statements is greater than can be reasonably accommodated during the meeting, the International Trade Administration may conduct a lottery to determine the speakers.</P>
                <P>
                    Any member of the public may submit written comments concerning the CINTAC's affairs at any time before or after the meeting. Comments may be submitted to Mr. Jonathan Chesebro at 
                    <E T="03">Jonathan.chesebro@trade.gov.</E>
                     For consideration during the meeting, and to ensure transmission to the Committee prior to the meeting, comments must be received no later than 5:00 p.m. EDT on Friday, October 29, 2021. Comments received after that date will be distributed to the members but may not be considered at the meeting.
                    <PRTPAGE P="58641"/>
                </P>
                <P>Copies of CINTAC meeting minutes will be available within 90 days of the meeting.</P>
                <SIG>
                    <DATED>Dated: October 15, 2021.</DATED>
                    <NAME>Man Cho,</NAME>
                    <TITLE>Deputy Director, Office of Energy and Environmental Industries.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23033 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-DR-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[RTID 0648-XB449]</DEPDOC>
                <SUBJECT>Taking of Threatened or Endangered Marine Mammals Incidental to Commercial Fishing Operations; Proposed Issuance of 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 National Marine Fisheries Service (NMFS) is proposing to issue a permit to authorize the incidental, but not intentional, take of specific Endangered Species Act (ESA)-listed marine mammal species or stocks under the Marine Mammal Protection Act (MMPA), in the WA/OR/CA sablefish pot fishery.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments on this action and supporting documents must be received by November 8, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments on the proposed permit and the preliminary determination supporting the permit, identified by NOAA-NMFS-2021-0092, through the Federal e-Rulemaking Portal:</P>
                    <P>
                        1. Go to 
                        <E T="03">https://www.regulations.gov</E>
                         and enter NOAA-NMFS-2021-0092 in the Search box.
                    </P>
                    <P>2. Click the “Comment” icon, and complete the required fields.</P>
                    <P>3. Enter or attach your comments.</P>
                    <P>
                        <E T="03">Instructions:</E>
                         NMFS may not consider comments if they are sent by any other method, to any other address or individual, or received after the end of the comment period. Due to delays in processing mail related to COVID-19 and health and safety concerns, no mail, courier, or hand deliveries will be accepted. All comments received are a part of the public record and will generally be posted for public viewing on 
                        <E T="03">www.regulations.gov</E>
                         without change. All personal identifying information (
                        <E T="03">e.g.,</E>
                         name, address, etc.), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous). Attachments to electronic comments will be accepted in Microsoft Word, Excel, or Adobe PDF file formats only.
                    </P>
                    <P>
                        The preliminary determination supporting the permit is available on the internet at 
                        <E T="03">https://www.regulations.gov/docket/NOAA-NMFS-2021-0092.</E>
                         Other supporting information is available on the internet including: Recovery plans for the ESA-listed marine mammal species, 
                        <E T="03">https://www.fisheries.noaa.gov/national/endangered-species-conservation/recovery-species-under-endangered-species-act;</E>
                         2021 MMPA List of Fisheries (LOF), 
                        <E T="03">https://www.fisheries.noaa.gov/national/marine-mammal-protection/list-fisheries-summary-tables;</E>
                         the most recent Marine Mammal Stock Assessment Reports (SAR) by region, 
                        <E T="03">https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessment-reports-region,</E>
                         and stock, 
                        <E T="03">https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessment-reports-species-stock;</E>
                         and Take Reduction Teams and Plans, 
                        <E T="03">https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-take-reduction-plans-and-teams.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Tina Fahy, NMFS West Coast Region, (562) 980-4023, 
                        <E T="03">Christina.Fahy@noaa.gov;</E>
                         or Jaclyn Taylor, NMFS Office of Protected Resources, (301) 427-8402, 
                        <E T="03">Jaclyn.Taylor@noaa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The MMPA requires NMFS to authorize the incidental take of ESA-listed marine mammals in commercial fisheries provided it can make the following determinations: (1) The incidental mortality and serious injury (M/SI) from commercial fisheries will have a negligible impact on the affected species or stocks; (2) a recovery plan for all affected species or stocks of threatened or endangered marine mammals has been developed or is being developed; and (3) where required under MMPA section 118, a take reduction plan has been developed or is being developed, a monitoring program is implemented, and vessels participating in the fishery are registered. We have made a preliminary determination that the WA/OR/CA sablefish pot fishery meets these three requirements and propose to issue a permit to the fishery to authorize the incidental take of ESA-listed marine mammal species or stocks under the MMPA for a period of three years. We solicit public comments on the proposed issuance of the permit and the underlying preliminary determination.</P>
                <HD SOURCE="HD2">Background</HD>
                <P>
                    The MMPA LOF classifies each commercial fishery as a Category I, II, or III fishery based on the level of mortality and injury of marine mammals occurring incidental to each fishery as defined in 50 CFR 229.2. Category I and II fisheries must register with NMFS and are subsequently authorized to incidentally take marine mammals during commercial fishing operations. However, that authorization is limited to those marine mammals that are not listed as threatened or endangered under the ESA. Section 101(a)(5)(E) of the MMPA, 16 U.S.C. 1371, states that NMFS, as delegated by the Secretary of Commerce, for a period of up to three years shall allow the incidental, but not intentional, taking of marine mammal stocks designated as depleted because of their listing as an endangered species or threatened species under the ESA, 16 U.S.C. 1531 
                    <E T="03">et seq.,</E>
                     by persons using vessels of the United States and those vessels which have valid fishing permits issued by the Secretary in accordance with section 204(b) of the Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C. 1824(b), while engaging in commercial fishing operations, if NMFS makes certain determinations. NMFS must determine, after notice and opportunity for public comment, that: (1) Incidental M/SI from commercial fisheries will have a negligible impact on the affected species or stock; (2) a recovery plan has been developed or is being developed for such species or stock under the ESA; and (3) where required under section 118 of the MMPA, a monitoring program has been established, vessels engaged in such fisheries are registered in accordance with section 118 of the MMPA, and a take reduction plan has been developed or is being developed for such species or stock.
                </P>
                <P>
                    The LOF includes a list of marine mammal species or stocks incidentally killed or injured in each commercial fishery. We evaluated ESA-listed stocks or species included on the 2021 MMPA LOF as killed or seriously injured following NMFS' Procedural Directive 02-238 “Process for Distinguishing Serious from Non-Serious Injury of Marine Mammals.” Based on this evaluation, we propose to issue a permit under MMPA section 101(a)(5)(E) to vessels registered in the Category II WA/OR/CA sablefish pot fishery, as classified on the final 2021 MMPA LOF, to incidentally kill or seriously injure 
                    <PRTPAGE P="58642"/>
                    the CA/OR/WA stock of humpback whale.
                </P>
                <P>
                    NMFS will regularly evaluate other commercial fisheries for purposes of making a negligible impact determination (NID) and issuing MMPA section 101(a)(5)(E) authorizations with the annual LOF as new information becomes available. More information about the WA/OR/CA sablefish pot fishery is available in the 2021 MMPA LOF (86 FR 3028; January 14, 2021) and on the internet at: 
                    <E T="03">https://www.fisheries.noaa.gov/national/marine-mammal-protection/list-fisheries-summary-tables.</E>
                </P>
                <P>
                    We reviewed the best available scientific information to determine if the WA/OR/CA sablefish pot fishery met the three requirements of MMPA section 101(a)(5)(E) for issuing a permit. This information is included in the 2021 MMPA LOF (86 FR 3028; January 14, 2021), the SAR for CA/OR/WA stock of humpback whale (available at: 
                    <E T="03">https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessment-reports</E>
                    ), the humpback whale recovery plan (available at: 
                    <E T="03">https://www.fisheries.noaa.gov/national/endangered-species-conservation/recovery-species-under-endangered-species-act</E>
                    ), and other relevant information, as detailed further in the document describing the preliminary determination supporting the permit (available at:
                    <E T="03"> https://www.regulations.gov/docket/NOAA-NMFS-2021-0092</E>
                    ).
                </P>
                <P>
                    NMFS is in the process of revising humpback whale stock structure under the MMPA in light of the 14 Distinct Population Segments (DPSs) established under the ESA (81 FR 62259, September 8, 2016), based on the recently finalized “Procedural Directive 02-204-03: Reviewing and Designating Stocks and Issuing Stock Assessment Reports under the Marine Mammal Protection Act” (NMFS 2019). The DPSs that occur in waters under the jurisdiction of the United States do not align with the existing MMPA stocks. Some of the listed DPSs partially coincide with the currently defined stocks. Because we cannot manage one portion of an MMPA stock as ESA-listed and another portion of a stock as not ESA-listed, until such time as the MMPA stock designations are revised in light of the ESA DPSs, NMFS continues to use the existing MMPA stock structure for MMPA management purposes (
                    <E T="03">e.g.,</E>
                     selection of a recovery factor, stock status) and treats such stocks as ESA-listed if a component of that stock is listed under the Act and overlaps with the analyzed commercial fishery.
                </P>
                <HD SOURCE="HD1">Basis for Determining Negligible Impact</HD>
                <P>Prior to issuing a MMPA 101(a)(5)(E) permit to take ESA-listed marine mammals incidental to commercial fishing, NMFS must determine if the M/SI incidental to commercial fisheries will have a negligible impact on the affected marine mammal species or stocks. NMFS satisfies this requirement by making a NID. Although the MMPA does not define “negligible impact,” NMFS has issued regulations providing a qualitative definition of “negligible impact,” defined in 50 CFR 216.103 as “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to adversely affect the species or stock through effects on annual rates of recruitment or survival.”</P>
                <HD SOURCE="HD1">Criteria for Determining Negligible Impact</HD>
                <P>
                    NMFS relies on a quantitative approach for determining negligible impact detailed in NMFS Procedural Directive 02-204-02 (directive), “Criteria for Determining Negligible Impact under MMPA section 101(a)(5)(E),” which became effective on June 17, 2020 (NMFS 2020). The procedural directive is available online at: 
                    <E T="03">https://www.fisheries.noaa.gov/national/laws-and-policies/protected-resources-policy-directives.</E>
                     This directive describes NMFS' process for determining whether incidental M/SI from commercial fisheries will have a negligible impact on ESA-listed marine mammal species/stocks (the first requirement necessary for issuing a MMPA section 101(a)(5)(E) permit as noted above).
                </P>
                <P>
                    The directive first describes the derivation of two Negligible Impact Thresholds (NIT), which represent levels of removal from a marine mammal species or stock. The first, Total Negligible Impact Threshold (NIT
                    <E T="52">t</E>
                    ), represents the 
                    <E T="03">total</E>
                     amount of human-caused M/SI that NMFS considers negligible for a given stock. The second, lower threshold, Single NIT (NIT
                    <E T="52">s</E>
                    ) represents the level of M/SI from a 
                    <E T="03">single commercial fishery</E>
                     that NMFS considers negligible for a stock. NIT
                    <E T="52">s</E>
                     was developed in recognition that some stocks may experience non-negligible levels of total human-caused M/SI but one or more individual fisheries may contribute a very small portion of that M/SI, and the effect of an individual fishery may be considered negligible.
                </P>
                <P>
                    The directive describes a detailed process for using these NIT values to conduct a NID analysis for each fishery classified as a Category I or II fishery on the MMPA LOF. The NID process uses a two-tiered analysis. The Tier 1 analysis first compares the total human-caused M/SI for a particular stock to NIT
                    <E T="52">t</E>
                    . If NIT
                    <E T="52">t</E>
                     is not exceeded, then all commercial fisheries that kill or seriously injure the stock are determined to have a negligible impact on the particular stock. If NIT
                    <E T="52">t</E>
                     is exceeded, then the Tier 2 analysis compares each individual fishery's M/SI for a particular stock to NIT
                    <E T="52">s</E>
                    . If NIT
                    <E T="52">s</E>
                     is not exceeded, then the commercial fishery is determined to have a negligible impact on that particular stock. For transboundary, migratory stocks, because of the uncertainty regarding the M/SI that occurs outside of U.S. waters, we assume that total M/SI exceeds NIT
                    <E T="52">t</E>
                     and proceed directly to the Tier 2 NIT
                    <E T="52">s</E>
                     analysis. If a commercial fishery has a negligible impact across all ESA-listed stocks, then the first of three findings necessary for issuing a MMPA 101(a)(5)(E) permit to the commercial fishery has been met (
                    <E T="03">i.e.,</E>
                     a negligible impact determination). If a commercial fishery has a non-negligible impact on any ESA-listed stock, then NMFS cannot issue a MMPA 101(a)(5)(E) permit for the fishery to incidentally take ESA-listed marine mammals.
                </P>
                <P>These NID criteria rely on the best available scientific information, including estimates of a stock's minimum population size and human-caused M/SI levels, as published in the most recent SARs and other supporting documents, as appropriate. Using these inputs, the quantitative negligible impact thresholds allow for straightforward calculations that lead to clear negligible or non-negligible impact determinations for each commercial fishery analyzed. In rare cases, robust data may be unavailable for a straightforward calculation, and the directive provides instructions for completing alternative calculations or assessments where appropriate.</P>
                <HD SOURCE="HD1">Negligible Impact Determination</HD>
                <P>
                    We evaluated the impact of the WA/OR/CA sablefish pot fishery following the directive, and, based on the best available scientific information, made a draft NID. The NID analysis is presented in accompanying MMPA 101(a)(5)(E) determination document that provides summaries of the information used to evaluate each ESA-listed stock documented on the 2021 MMPA LOF as killed or injured incidental to the fishery. An estimate of mean annual commercial fishery-related M/SI is available for the CA/OR/WA stock of humpback whale in the most recent SAR. The SAR also includes unattributed fishery-related M/SI for the 
                    <PRTPAGE P="58643"/>
                    stock but not assigned to a specific commercial fishery. Because data are not currently available to assign the unattributed fishery-related M/SI to a specific commercial fishery, it was not accounted for in the NID analysis. The draft MMPA 101(a)(5)(E) determination document is available at: 
                    <E T="03">https://www.regulations.gov/docket/NOAA-NMFS-2021-0092.</E>
                     Based on the criteria outlined in the directive, the most recent SAR, and the best available scientific information, NMFS has determined that the M/SI incidental to the Category II WA/OR/CA sablefish pot fishery will have a negligible impact on the associated ESA-listed marine mammal stock. Accordingly, this MMPA 101(a)(5)(E) requirement is satisfied for the commercial fishery.
                </P>
                <HD SOURCE="HD1">Recovery Plan</HD>
                <P>
                    The humpback whale recovery plan has been completed (see 
                    <E T="03">https://www.fisheries.noaa.gov/national/endangered-species-conservation/recovery-species-under-endangered-species-act</E>
                    ). Accordingly, the requirement to have a recovery plan in place or being developed is satisfied.
                </P>
                <HD SOURCE="HD1">Take Reduction Plan</HD>
                <P>Subject to available funding, MMPA section 118 requires the development and implementation of a Take Reduction Plan (TRP) for each strategic stock that interacts with a Category I or II fishery. The stock considered for this permit is designated as a strategic stock under the MMPA because the stock, or a component of the stock, is listed as threatened or endangered under the ESA (MMPA section 3(19)(C)).</P>
                <P>
                    The short- and long-term goals of a TRP are to reduce M/SI of marine mammals incidental to commercial fishing to levels below the Potential Biological Removal (PBR) level for stocks and to an insignificant threshold, defined by NMFS as 10 percent of PBR, respectively. The obligations to develop and implement a TRP are subject to the availability of funding. MMPA section 118(f)(3) (16 U.S.C. 1387(f)(3)) contains specific priorities for developing TRPs when funding is insufficient. NMFS has insufficient funding available to simultaneously develop and implement TRPs for all strategic stocks that interact with Category I or Category II fisheries. As provided in MMPA section 118(f)(6)(A) and (f)(7), NMFS uses the most recent SAR and LOF as the basis to determine its priorities for establishing Take Reduction Teams (TRT) and developing TRPs. Information about NMFS' marine mammal TRTs and TRPs may be found at: 
                    <E T="03">https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-take-reduction-plans-and-teams.</E>
                </P>
                <P>
                    Based on NMFS' priorities, implementation of a TRP for the WA/OR/CA sablefish pot fishery is currently deferred under MMPA section 118 as other stocks/fisheries are a higher priority for any available funding. Accordingly, the requirement under MMPA section 118 to have TRPs in place or in development is satisfied (see preliminary determination supporting the permit available on the internet at 
                    <E T="03">https://www.regulations.gov/docket/NOAA-NMFS-2021-0092</E>
                    ).
                </P>
                <HD SOURCE="HD1">Monitoring Program</HD>
                <P>Under MMPA section 118(d), NMFS is to establish a program for monitoring incidental M/SI of marine mammals from commercial fishing operations. The WA/OR/CA sablefish pot fishery is the subject of a NMFS fishery observer program. Accordingly, the requirement under MMPA section 118 to have a monitoring program in place is satisfied.</P>
                <HD SOURCE="HD1">Vessel Registration</HD>
                <P>MMPA section 118(c) requires that vessels participating in Category I and II fisheries register to obtain an authorization to take marine mammals incidental to fishing activities. NMFS has integrated the MMPA registration process, implemented through the Marine Mammal Authorization Program, with existing state and Federal fishery license, registration, or permit systems for Category I and II fisheries on the LOF. Therefore, the requirement for vessel registration is satisfied.</P>
                <HD SOURCE="HD1">Conclusions for Proposed Permit</HD>
                <P>Based on the above evaluation for the WA/OR/CA sablefish pot fishery as it relates to the three requirements of MMPA 101(a)(5)(E), we propose to issue a MMPA 101(a)(5)(E) permit to the commercial fishery to authorize the incidental take of ESA-listed species or stocks during commercial fishing operations. If, during the 3-year authorization, there is a significant change in the information or conditions used to support any of these determinations, NMFS will re-evaluate whether to amend or modify the authorization, after notice and opportunity for public comment. NMFS solicits public comments on the proposed permit and the preliminary determination supporting the permit.</P>
                <HD SOURCE="HD1">ESA Section 7 and National Environmental Policy Act Requirements</HD>
                <P>ESA section 7(a)(2) requires federal agencies to ensure that actions they authorize, fund, or carry out do not jeopardize the existence of any species listed under the ESA, or destroy or adversely modify designated critical habitat of any ESA-listed species. The effects of the WA/OR/CA sablefish pot fishery on ESA-listed marine mammals for which a permit is proposed here were analyzed in the appropriate ESA section 7 Biological Opinion on the commercial fishery, and incidental take was exempted for those ESA-listed marine mammals for the fishery.</P>
                <P>Under section 7 of the ESA, Biological Opinions quantify the effects of the proposed action on ESA-listed species and their critical habitat and, where appropriate, authorize anticipated future take of ESA-listed species as specified in the incidental take statement. Under MMPA section 101(a)(5)(E), NMFS analyzes previously documented M/SI incidental to commercial fisheries through the negligible impact determination process, and when the necessary findings can be made, issues a MMPA section 101(a)(5)(E) permit that allows for an unspecified amount of incidental taking of specific ESA-listed marine mammal stocks while engaging in commercial fishing operations. Thus, the applicable standards and resulting analyses under the MMPA and ESA differ, and as such, may not always align. The National Environmental Policy Act (NEPA) requires Federal agencies to evaluate the impacts of alternatives for their actions on the human environment. Because the proposed permit would not modify any fishery operation and the effects of the fishery operations have been evaluated in accordance with NEPA, no additional NEPA analysis beyond that conducted for the associated Fishery Management Plans is required for the permit. Issuing the proposed permit would have no additional impact on the human environment or effects on threatened or endangered species beyond those analyzed in these documents.</P>
                <HD SOURCE="HD1">References</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        National Marine Fisheries Service (NMFS). 2020. National Marine Fisheries Service Procedure 02-204-02: Criteria for Determining Negligible Impact under MMPA Section 101(a)(5)(E). 20 p. Available online: 
                        <E T="03">https://www.fisheries.noaa.gov/national/laws-and-policies/protected-resources-policy-directives</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        National Marine Fisheries Service (NMFS). 2019. National Marine Fisheries Service Procedure 02-204-03: Reviewing and designating stocks and issuing Stock Assessment Reports under the Marine Mammal Protection Act. 9 p. Available online: 
                        <E T="03">
                            https://www.fisheries.noaa.gov/national/laws-and-policies/protected-
                            <PRTPAGE P="58644"/>
                            resources-policy-directives
                        </E>
                    </FP>
                    <FP SOURCE="FP-2">
                        National Marine Fisheries Service (NMFS). 2016. National Marine Fisheries Service Procedure 02-204-01: Guidelines for preparing stock assessment reports pursuant to the 1994 amendments to the Marine Mammal Protection Act. 23 p. Available online: 
                        <E T="03">https://www.fisheries.noaa.gov/national/marine-mammal-protection/guidelines-assessing-marine-mammal-stocks</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        National Marine Fisheries Service (NMFS). 2014. National Marine Fisheries Service Procedure 02-238-01: Process for Distinguishing Serious from Non-Serious Injury of Marine Mammals. 42 p. Available online: 
                        <E T="03">https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-protection-act-policies-guidance-and-regulations</E>
                    </FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>Kimberly Damon-Randall,</NAME>
                    <TITLE>Director, Office of Protected Resources, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23047 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-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>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Additions to the Procurement List.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This action adds product(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 and deleted from the Procurement List:</E>
                         November 21, 2021.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S Clark Street, Suite 715, Arlington, Virginia, 22202-4149.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Michael R. Jurkowski, Telephone: (703) 785-6404, Fax: (703) 603-0655, 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 1/15/2021, 6/4/2021, and 6/18/2021, 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 product(s) and impact of the additions on the current or most recent contractors, the Committee has determined that the product(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="HD1">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 product(s) and service(s) to the Government.</P>
                <P>2. The action will result in authorizing small entities to furnish the product(s) and 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 product(s) and service(s) proposed for addition to the Procurement List.</P>
                <HD SOURCE="HD1">End of Certification</HD>
                <P>Accordingly, the following product(s) are added to the Procurement List:</P>
                <EXTRACT>
                    <HD SOURCE="HD2">Product(s)</HD>
                    <FP SOURCE="FP-2">
                        <E T="03">NSN(s)—Product Name(s):</E>
                    </FP>
                    <FP SOURCE="FP1-2">MR 10791—Pot Lid Stand, Includes Shipper 20791</FP>
                    <FP SOURCE="FP1-2">MR 10789—Pizza Slicer and Server, Includes Shipper 20789</FP>
                    <FP SOURCE="FP1-2">MR 13154—Sauce Pan, 2 QT</FP>
                    <FP SOURCE="FP1-2">MR 10810—Snack Bowl, Includes Shipper 20810</FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Mandatory Source of Supply:</E>
                         Winston-Salem Industries for the Blind, Inc., Winston-Salem, NC
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Mandatory For: The requirements of military commissaries and exchanges in accordance with the 41 CFR 51-6.4</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Contracting Activity:</E>
                         Military Resale-Defense Commissary Agency
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Distribution:</E>
                         C-List
                    </FP>
                </EXTRACT>
                <SIG>
                    <NAME>Michael R. Jurkowski,</NAME>
                    <TITLE>Acting Director, Business Operations.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23080 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6353-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED</AGENCY>
                <SUBJECT>Procurement List; Proposed Additions and Deletions</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Committee for Purchase From People Who Are Blind or Severely Disabled.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed additions to and deletions from the Procurement List.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Committee is proposing to add product(s) and service(s) to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities and deletes product(s) and service(s) previously furnished by such agencies.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Comments must be received on or before:</E>
                         November 21, 2021.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S Clark Street, Suite 715, Arlington, Virginia 22202-4149.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For further information or to submit comments contact: 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>
                <P>This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.</P>
                <HD SOURCE="HD1">Additions</HD>
                <P>If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the product(s) and service(s) listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.</P>
                <P>The following product(s) and service(s) are proposed for addition to the Procurement List for production by the nonprofit agencies listed:</P>
                <EXTRACT>
                    <HD SOURCE="HD2">Product(s)</HD>
                    <FP SOURCE="FP-2">
                        <E T="03">NSN(s)—Product Name(s):</E>
                         7025-00-NIB-0023—Monitor, Portable, Black, 15″-17″ Laptops
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Designated Source of Supply:</E>
                         Asso. for the Blind and Visually Impaired-Goodwill Industries of Greater Rochester, Inc., Rochester, NY
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Contracting Activity:</E>
                         DEFENSE LOGISTICS AGENCY, DLA TROOP SUPPORT
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Mandatory for:</E>
                         Total Government Requirement
                    </FP>
                    <P>
                        <E T="03">Distribution:</E>
                         A-List
                    </P>
                    <FP SOURCE="FP-2">
                        <E T="03">NSN(s)—Product Name(s)</E>
                    </FP>
                    <FP SOURCE="FP1-2">5180-00-NIB-0156—Kit, Pro-Grade Tool, 6 PC</FP>
                    <FP SOURCE="FP1-2">5180-00-NIB-0160—Kit, Pro-Grade Tool, 14 PC</FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Designated Source of Supply:</E>
                         Industries for the Blind and Visually Impaired, Inc., West Allis, WI
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Contracting Activity:</E>
                         FEDERAL ACQUISITION SERVICE, FAS HEARTLAND REGIONAL ADMINISTRATOR
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Mandatory for:</E>
                         Broad Government Requirement
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Distribution:</E>
                         B-List
                        <PRTPAGE P="58645"/>
                    </FP>
                    <HD SOURCE="HD2">Service(s)</HD>
                    <FP SOURCE="FP-2">
                        <E T="03">Service Type:</E>
                         Facility Support Services
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Mandatory for:</E>
                         National Park Service, National Capital Region Office Headquarters, Washington, DC
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Designated Source of Supply:</E>
                         Portco, Inc., Portsmouth, VA
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Contracting Activity:</E>
                         NATIONAL PARK SERVICE, NCR REGIONAL CONTRACTING(30000)
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Service Type:</E>
                         Custodial Service
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Mandatory for:</E>
                         FAA, Multiple Locations, Key West, FL
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Designated Source of Supply:</E>
                         Mavagi Enterprises, Inc., San Antonio, TX
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Contracting Activity:</E>
                         FEDERAL AVIATION ADMINISTRATION, 697DCK REGIONAL ACQUISITIONS SVCS
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Service Type:</E>
                         Plant Maintenance Services
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Mandatory for:</E>
                         GSA PBS Region 5, Minton-Capehart Federal Building, Indianapolis, IN
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Designated Source of Supply:</E>
                         GW Commercial Services, Inc., Indianapolis, IN
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Contracting Activity:</E>
                         PUBLIC BUILDINGS SERVICE, PBS R5
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Service Type:</E>
                         Administrative Support Service
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Mandatory for:</E>
                         USCIS, Corbin Production Facility, Corbin, KY
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Designated Source of Supply:</E>
                         PRIDE Industries, Roseville, CA
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Contracting Activity:</E>
                         U.S. CITIZENSHIP AND IMMIGRATION SERVICES, USCIS CONTRACTING OFFICE(ERBUR)
                    </FP>
                </EXTRACT>
                <HD SOURCE="HD1">Deletions</HD>
                <P>The following product(s) and service(s) are proposed for deletion from the Procurement List:</P>
                <EXTRACT>
                    <HD SOURCE="HD2">Product(s)</HD>
                    <FP SOURCE="FP-2">
                        <E T="03">NSN(s)—Product Name(s)</E>
                    </FP>
                    <FP SOURCE="FP1-2">8420-01-540-0611—Undershirt, Man's, Navy Blue, XX-Small</FP>
                    <FP SOURCE="FP1-2">8420-01-540-0612—Undershirt, Man's, Navy Blue, X-Small</FP>
                    <FP SOURCE="FP1-2">8420-01-540-0614—Undershirt, Man's, Navy Blue, Small</FP>
                    <FP SOURCE="FP1-2">8420-01-540-1758—Undershirt, Man's, Navy Blue, Medium</FP>
                    <FP SOURCE="FP1-2">8420-01-540-1759—Undershirt, Man's, Navy Blue, Large</FP>
                    <FP SOURCE="FP1-2">8420-01-540-1760—Undershirt, Man's, Navy Blue, X-Large</FP>
                    <FP SOURCE="FP1-2">8420-01-540-1761—Undershirt, Man's, Navy Blue, XX-Large</FP>
                    <FP SOURCE="FP1-2">8420-01-540-1762—Undershirt, Man's, Navy Blue, XXX-Large</FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Designated Source of Supply:</E>
                         Winston-Salem Industries for the Blind, Inc., Winston-Salem, NC
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Contracting Activity:</E>
                         DLA TROOP SUPPORT, PHILADELPHIA, PA
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">NSN(s)—Product Name(s)</E>
                    </FP>
                    <FP SOURCE="FP1-2">8420-01-540-0611—Undershirt, Man's, Navy Blue, XX-Small</FP>
                    <FP SOURCE="FP1-2">8420-01-540-0612—Undershirt, Man's, Navy Blue, X-Small</FP>
                    <FP SOURCE="FP1-2">8420-01-540-0614—Undershirt, Man's, Navy Blue, Small</FP>
                    <FP SOURCE="FP1-2">8420-01-540-1758—Undershirt, Man's, Navy Blue, Medium</FP>
                    <FP SOURCE="FP1-2">8420-01-540-1759—Undershirt, Man's, Navy Blue, Large</FP>
                    <FP SOURCE="FP1-2">8420-01-540-1760—Undershirt, Man's, Navy Blue, X-Large</FP>
                    <FP SOURCE="FP1-2">8420-01-540-1761—Undershirt, Man's, Navy Blue, XX-Large</FP>
                    <FP SOURCE="FP1-2">8420-01-540-1762—Undershirt, Man's, Navy Blue, XXX-Large</FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Designated Source of Supply:</E>
                         The Arkansas Lighthouse for the Blind, Little Rock, AR
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Contracting Activity:</E>
                         DLA TROOP SUPPORT, PHILADELPHIA, PA
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">NSN(s)—Product Name(s)</E>
                    </FP>
                    <FP SOURCE="FP1-2">8105-LL-S05-4103—Polyethylene Bag, Hazardous Waste, 36″x48″x.008, Transparent Orange</FP>
                    <FP SOURCE="FP1-2">8105-LL-S05-4108—Polyethylene Bag, 16″x18″x.008, Transparent Green</FP>
                    <FP SOURCE="FP1-2">8105-LL-S05-4110—Polyethylene Bag, 24″x36″x.008, Transparent Green</FP>
                    <FP SOURCE="FP1-2">8105-LL-S05-4111—Polyethylene Bag, 36″x48″x.008, Transparent Green</FP>
                    <FP SOURCE="FP1-2">8105-LL-S05-4113—Polyethylene Bag, Hazardous Waste, 24″x36″x.008, T</FP>
                    <FP SOURCE="FP1-2">8105-LL-S05-4114—Polyethylene Bag, Hazardous Waste, 16″x18″x.008, Transparent Orange</FP>
                    <FP SOURCE="FP1-2">8105-LL-S05-4142—Polyethylene Bag, 24″x10″x48,″ Transparent White</FP>
                    <FP SOURCE="FP1-2">8105-LL-S05-4143—Polyethylene Bag, 24″x10″x36,″ Transparent White</FP>
                    <FP SOURCE="FP1-2">8105-LL-S05-4107—Polyethylene Bag, 24″x48″x.008, Transparent Green</FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Designated Source of Supply:</E>
                         Open Door Center, Valley City, ND
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Contracting Activity:</E>
                         DLA MARITIME—PUGET SOUND, BREMERTON, WA
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">NSN(s)—Product Name(s):</E>
                         8105-LL-S05-4109—Polyethylene Bag, 14″x48″x.008, Transparent Green
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Designated Source of Supply:</E>
                         Open Door Center, Valley City, ND
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Contracting Activity:</E>
                         DLA MARITIME—PUGET SOUND, BREMERTON, WA
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">NSN(s)—Product Name(s)</E>
                    </FP>
                    <FP SOURCE="FP1-2">8105-LL-S04-8618—Bag, Polyethylene, Landfill Controlled Waste, 36″W x 48″L, Opaque Green</FP>
                    <FP SOURCE="FP1-2">8105-LL-S04-8619—Bag, Polyethylene, Landfill Controlled Waste, 24″W x 48″L, Opaque Green</FP>
                    <FP SOURCE="FP1-2">8105-LL-S04-8620—Bag, Polyethylene, Landfill Controlled Waste, 14″W x 48″L, Opaque Green</FP>
                    <FP SOURCE="FP1-2">8105-LL-S04-9831—Bag, Polyethylene, Landfill Controlled Waste, 24″W x 36″L, Opaque Green</FP>
                    <FP SOURCE="FP1-2">8105-LL-S05-0760—Bag, Polyethylene, Landfill Controlled Waste, 16″W x 18″L, Opaque Green</FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Designated Source of Supply:</E>
                         Open Door Center, Valley City, ND
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Contracting Activity:</E>
                         DLA MARITIME—PUGET SOUND, BREMERTON, WA
                    </FP>
                    <HD SOURCE="HD2">Service(s)</HD>
                    <FP SOURCE="FP-2">
                        <E T="03">Service Type:</E>
                         Mailroom Operation
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Mandatory for:</E>
                         Department of Health and Human Services: Program Support Center Headquarters, Dallas, TX
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Designated Source of Supply:</E>
                         Dallas Lighthouse for the Blind, Inc., Dallas, TX
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Contracting Activity:</E>
                         HEALTH AND HUMAN SERVICES, DEPARTMENT OF, DEPT OF HHS
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Service Type:</E>
                         Janitorial/Custodial
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Mandatory for:</E>
                         VA Medical Center: Dental Laboratory, Washington, DC
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Designated Source of Supply:</E>
                         Columbia Lighthouse for the Blind, Washington, DC
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Contracting Activity:</E>
                         VETERANS AFFAIRS, DEPARTMENT OF, NAC
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Service Type:</E>
                         Water System Hydrant Maintenance
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Mandatory for:</E>
                         US Army, Joint Base Lewis-McChord, Joint Base Lewis-McChord, WA 2140 Liggett Avenue Joint Base Lewis-McChord, WA
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Designated Source of Supply:</E>
                         Skookum Educational Programs, Bremerton, WA
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Contracting Activity:</E>
                         DEPT OF THE ARMY, W6QM MICC-JB LEWIS-MC CHORD
                    </FP>
                </EXTRACT>
                <SIG>
                    <NAME>Michael R. Jurkowski,</NAME>
                    <TITLE>Acting Director, Business Operations.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23079 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6353-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF DEFENSE</AGENCY>
                <DEPDOC>[Docket ID: DoD-2021-HA-0087]</DEPDOC>
                <SUBJECT>Submission for OMB Review; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of the Assistant Secretary of Defense for Health Affairs, Department of Defense (DoD).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>30-Day information collection notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Consideration will be given to all comments received by November 22, 2021.</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>
                        Angela Duncan, 571-372-7574, or 
                        <E T="03">whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P SOURCE="NPAR">
                    <E T="03">Title; Associated Form; and OMB Number:</E>
                     TRICARE DoD/CHAMPUS Medical Claim Patient's Request for Medical Payment; DD Form 2642; OMB Control Number 0720-0006.
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     Extension.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     830,000.
                </P>
                <P>
                    <E T="03">Responses per Respondent:</E>
                     1.
                </P>
                <P>
                    <E T="03">Annual Responses:</E>
                     830,000.
                </P>
                <P>
                    <E T="03">Average Burden per Response:</E>
                     15 Minutes.
                    <PRTPAGE P="58646"/>
                </P>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     207,500.
                </P>
                <P>
                    <E T="03">Needs and Uses:</E>
                     The DD-2642, “TRICARE DoD/CHAMPUS Medical Claim Patient's Request for Medical Payment” form is used by TRICARE beneficiaries to claim reimbursement for medical expenses under the TRICARE Program (formerly the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)). The information collected will be used by TRICARE to determine beneficiary eligibility, other health insurance liability, certification that the beneficiary has the received care, and reimbursement for medical services received.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individuals or households.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     As required.
                </P>
                <P>
                    <E T="03">Respondent's Obligation:</E>
                     Voluntary.
                </P>
                <P>
                    <E T="03">OMB Desk Officer:</E>
                     Ms. Julie Wise.
                </P>
                <P>You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:</P>
                <P>
                    • 
                    <E T="03">Federal eRulemaking Portal:</E>
                      
                    <E T="03">http://www.regulations.gov.</E>
                     Follow the instructions for submitting comments.
                </P>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the agency name, Docket ID number, and title for this 
                    <E T="04">Federal Register</E>
                     document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at 
                    <E T="03">http://www.regulations.gov</E>
                     as they are received without change, including any personal identifiers or contact information.
                </P>
                <P>
                    <E T="03">DOD Clearance Officer:</E>
                     Ms. Angela Duncan.
                </P>
                <P>
                    Requests for copies of the information collection proposal should be sent to Ms. Duncan at 
                    <E T="03">whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.</E>
                </P>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>Kayyonne T. Marston,</NAME>
                    <TITLE>Alternate OSD Federal Register Liaison Officer, Department of Defense.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23110 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 5001-06-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF EDUCATION</AGENCY>
                <DEPDOC>[Docket No.: ED-2021-SCC-0146]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Comment Request; Magnet Schools Assistance Program—Government Performance and Results Act (GPRA) Table Form</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Innovation and Improvement (OII), 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 of 1995, ED is proposing an extension without change of a currently approved collection.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested persons are invited to submit comments on or before December 21, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        To access and review all the documents related to the information collection listed in this notice, please use 
                        <E T="03">http://www.regulations.gov</E>
                         by searching the Docket ID number ED-2021-SCC-0146. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at 
                        <E T="03">http://www.regulations.gov</E>
                         by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. If the 
                        <E T="03">regulations.gov</E>
                         site is not available to the public for any reason, ED will temporarily accept comments at 
                        <E T="03">ICDocketMgr@ed.gov.</E>
                         Please include the docket ID number and the title of the information collection request when requesting documents or submitting comments. 
                        <E T="03">Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted.</E>
                         Written requests for information or comments submitted by postal mail or delivery should be addressed to the PRA Coordinator of the Strategic Collections and Clearance Governance and Strategy Division, U.S. Department of Education, 400 Maryland Ave., SW, LBJ, Room 6W208D, Washington, DC 20202-8240.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>For specific questions related to collection activities, please contact Gillian Cohen-Boyer, (202) 401-1259.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education 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>
                     Magnet Schools Assistance Program—Government Performance and Results Act (GPRA) Table Form.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1855-0025.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension without change of a currently approved collection.
                </P>
                <P>
                    <E T="03">Respondents/Affected Public:</E>
                     State, Local, and Tribal Governments.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Responses:</E>
                     162.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Burden Hours:</E>
                     81.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     This is a request for extension of a currently approved collection. The collection of this information is part of the government-wide effort to improve the performance and accountability of all federal programs, under the Government Performance and Results Act (GPRA) passed in 1993, the Uniform Guidance, and the Education Department General Administrative Requirements (EDGAR). Under GPRA, a process for using performance indicators to set program performance goals and to measure and report program results was established. To implement GPRA, the Department developed GPRA measures at every program level to quantify and report program progress required by the Elementary and Secondary Education Act of 1965, as amended. Under the Uniform Guidance and EDGAR, recipients of federal awards are required to submit performance and financial expenditure information. The GPRA program level measures and budget information for the Magnet Schools Assistance Program (MSAP) are reported in the Annual Performance Report (APR). The APR is required under 2 CFR 200.328 and 34 CFR 75.118 and 75.590. The annual report provides data on the status of the funded project that corresponds to the scope and objectives established in the approved application and any amendments. To ensure that accurate and reliable data are reported to Congress on program implementation and performance outcomes, the MSAP APR collects the raw data from grantees in a consistent format to calculate these data in the aggregate.
                </P>
                <SIG>
                    <PRTPAGE P="58647"/>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>Kate 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. 2021-23044 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4000-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF ENERGY</AGENCY>
                <SUBJECT>Agency Information Collection Extension</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Department of Energy.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Submission for Office of Management and Budget (OMB) review; comment request.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Energy (DOE) has submitted an information collection request to the OMB for extension under the provisions of the Paperwork Reduction Act of 1995. The information collection requests a three-year extension of its Security Information Collections, OMB Control Number 1910-1800. The proposed collection assists DOE in the protection of national security and other critical assets entrusted to the Department.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments regarding this collection must be received on or before November 22, 2021. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, please advise the OMB Desk Officer of your intention to make a submission as soon as possible. The Desk Officer may be telephoned at (202) 395-4718.</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>
                        Requests for additional information should be directed to Sandra Dentinger, U.S. Department of Energy, Office of Environment, Health, Safety and Security, AU-70/Germantown Building, 1000 Independence Avenue SW, Washington, DC 20585 by phone (301) 903-5139 or by email at: s
                        <E T="03">andra.dentinger@hq.doe.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    This information collection request contains: (1) 
                    <E T="03">OMB No.:</E>
                     1910-1800; (2) 
                    <E T="03">Information Collection Request Title:</E>
                     Security Information Collections; (3) 
                    <E T="03">Type of Request:</E>
                     Renewal; (4) 
                    <E T="03">Purpose:</E>
                     The purpose of this collection is to protect national security and other critical assets entrusted to the Department. (5) 
                    <E T="03">Annual Estimated Number of Respondents:</E>
                     75,661; (6) 
                    <E T="03">Annual Estimated Number of Total Responses:</E>
                     84,621; (7) 
                    <E T="03">Annual Estimated Number of Burden Hours:</E>
                     13,251; (8) 
                    <E T="03">Annual Estimated Reporting and Recordkeeping Cost Burden:</E>
                     $1,192,590.
                </P>
                <P>
                    <E T="03">Statutory Authority:</E>
                     Section 641 of the Department of Energy Organization Act, codified at 42 U.S.C. 7251, and the following additional authorities:
                </P>
                <P>DOE F 5631.34, Data Report on Spouse/Cohabitant: Section 145(b) of the Atomic Energy Act of 1954, as amended, codified at 42 U.S.C. 2165; Executive Order 12968 (August 2, 1995); Executive Order 10865 (February 20, 1960); Executive Order 10450 (April 27, 1953); DOE O 472.2 (July 21, 2011).</P>
                <P>Security Incident Notification Report and Report of Preliminary Security Incident/Infraction (DOE F 471.1 and DOE F 5639.3): Executive Order 13526 (December 29, 2009); 32 CFR part 2001; DOE O 470.4B (July 21, 2011).</P>
                <P>DOE F 5631.20, Request for Visitor Access Approval: Section 145(b) of the Atomic Energy Act of 1954, as amended, codified at 42 U.S.C. 2165.</P>
                <P>DOE Form 5631.18, Security Acknowledgement: Section 145(b) of the Atomic Energy Act of 1954, as amended, codified at 42 U.S.C. 2165; Executive Order 13526 (December 29, 2009); Executive Order 10865 (Feb. 20, 1960); Executive Order 10450 (April 27, 1953); DOE O 5631.2C (February 17, 1994).</P>
                <P>DOE Form 5631.29, Security Termination Statement: Section 145(b) of the Atomic Energy Act of 1954, as amended, codified at 42 U.S.C. 2165; Executive Order 13526 (December 29, 2009); Executive Order 10865 (Feb. 20, 1960); Executive Order 10450 (Apr. 27, 1953); 32 CFR part 2001; DOE O 472.2 (July 21, 2011).</P>
                <P>DOE Form 5631.5, The Conduct of Personnel Security Interviews: 10 CFR part 710; Executive Order 12968 (Aug. 2, 1995); Executive Order 10450 (April 27, 1953); DOE Order 472.2 (July 21, 2011).</P>
                <P>DOE F 473.3 U.S. Department of Energy Clearance Access Request DOE F 471.1, Security Incident Notification Report; DOE Form 472.3 Foreign Citizenship Acknowledgement; and DOE Form 473.2, Security Badge Request; the Atomic Energy Act of 1954, as amended, and by Executive Orders 13764, 10865, and 13526.</P>
                <P>Electronic Foreign Ownership, Control or Influence (e-FOCI) System: Executive Order 12829 (January 6, 1993); DOE O 470.4B (July 21, 2011).</P>
                <P>Foreign Access Central Tracking System (FACTS): Presidential Decision Directive 61 (February 1999); DOE O 142.3A (October 14, 2010).</P>
                <HD SOURCE="HD1">Signing Authority</HD>
                <P>
                    This document of the Department of Energy was signed on October 18, 2021, by Matthew B. Moury, Associate Under Secretary for Environment, Health, Safety and Security, 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>
                    <DATED>Signed in Washington, DC, on October 19, 2021.</DATED>
                    <NAME>Treena V. Garrett,</NAME>
                    <TITLE>Federal Register Liaison Officer, U.S. Department of Energy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23050 Filed 10-21-21; 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>
                <DEPDOC>[Docket No. ER22-123-000]</DEPDOC>
                <SUBJECT>Hecate Energy Highland 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 Hecate Energy Highland 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.
                    <PRTPAGE P="58648"/>
                </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 November 8, 2021.</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: October 18, 2021.</DATED>
                    <NAME>Debbie-Anne A. Reese,</NAME>
                    <TITLE>Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23111 Filed 10-21-21; 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</SUBJECT>
                <P>Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:</P>
                <HD SOURCE="HD1">Filings Instituting Proceedings</HD>
                <P>
                    <E T="03">Docket Numbers:</E>
                     RP22-50-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Natural Gas Pipeline Company of America LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 4(d) Rate Filing: Negotiated Rate Agreement Filing—BP Energy Company to be effective 11/1/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     10/15/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20211015-5061.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 10/27/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     RP22-51-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Natural Gas Pipeline Company of America LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 4(d) Rate Filing: Negotiated Rate Agreement Filing—Macquarie Energy LLC to be effective 11/1/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     10/15/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20211015-5062.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 10/27/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     RP22-52-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Double E Pipeline, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 4(d) Rate Filing: Double E Pipeline, LLC—Negotiated Rate and Non-Conforming Agreements to be effective 11/15/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     10/15/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20211015-5124.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 10/27/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     RP22-53-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Northwest Pipeline LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 4(d) Rate Filing: 2021 Housekeeping Filing to be effective 11/15/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     10/15/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20211015-5125.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 10/27/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     RP22-54-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Midcontinent Express Pipeline LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 4(d) Rate Filing: NextEra FTS Negotiated Rate to be effective 11/1/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     10/18/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20211018-5038.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 11/1/21.
                </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: October 18, 2021.</DATED>
                    <NAME>Debbie-Anne A. Reese,</NAME>
                    <TITLE>Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23114 Filed 10-21-21; 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 corporate filings:</P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     EC22-4-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Sagebrush, a California partnership, Sagebrush Line, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Application for Authorization Under Section 203 of the Federal Power Act of Sagebrush, a California partnership, et al.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     10/18/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20211018-5099.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 11/8/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     EC22-5-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Rev Renewables, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Application for Authorization Under Section 203 of the Federal Power Act of Rev Renewables, LLC.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     10/18/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20211018-5106.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 11/8/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     EC22-6-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     DESRI Holdings, L.P., Airport Solar LLC, Assembly Solar, LLC, Assembly Solar I, LLC, Assembly Solar II, LLC, Assembly Solar III, LLC, Balko Wind, LLC, Balko Wind Transmission, LLC, Big River Solar, LLC, Cuyama Solar, LLC, Cove Mountain Solar, LLC, Cove Mountain Solar 2, LLC, Dressor Plains Solar, LLC, Drew Solar, LLC, Drew Solar-CA, LLC, DWW Solar II, LLC, Gray Hawk Solar, LLC, Hecate Energy Highland LLC, Hunter Solar LLC, Iris Solar, LLC, MS Solar 2, LLC, North Star Solar PV LLC, Portal Ridge Solar B, LLC, Portal Ridge Solar C, LLC, Prairie State Solar, LLC, Rancho Seco Solar, LLC, Rancho Seco Solar II LLC, Red Horse III, LLC, Red Horse Wind 2, LLC, Sigurd Solar LLC, St. James Solar, LLC, TPE Alta Luna, LLC, Willow Springs Solar, LLC, 62SK 8ME LLC, 63SU 8ME LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Joint Application for Authorization Under Section 203 of the Federal Power Act of DESRI Holdings, L.P., et al.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     10/15/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20211015-5216.
                    <PRTPAGE P="58649"/>
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 11/5/21.
                </P>
                <P>Take notice that the Commission received the following Complaints and Compliance filings in EL Dockets:</P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     EL22-3-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Flint Mine Solar LLC v. New York Independent System Operator, Inc.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Complaint of Flint Mine Solar LLC v. Independent System Operator, Inc.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     10/14/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20211014-5172,
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 10/25/21,
                </P>
                <P>Take notice that the Commission received the following electric rate filings:</P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER16-323-009.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Ohio Valley Electric Corporation.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Supplement to December 18, 2020 Triennial Market Power Analysis for Central Region of Ohio Valley Electric Corporation.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     10/6/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20211006-5140.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 10/27/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER22-126-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Southwest Power Pool, Inc.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: 3862&amp;3863 SWEPCO/ETEC/Rayburn Early Termination Ag/Letter Ag to be effective 12/18/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     10/18/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20211018-5051.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 11/8/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER22-127-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     PJM Interconnection, L.L.C.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Tariff Amendment: Notice of Cancellation of Interim ISA, SA No. 5848; Queue No. AD1-087/AD2-202 to be effective 10/11/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     10/18/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20211018-5073.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 11/8/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER22-128-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     American Electric Power Service Corporation, Ohio Power Company, AEP Ohio Transmission Company, Inc., PJM Interconnection, L.L.C.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: American Electric Power Service Corporation submits tariff filing per 35.13(a)(2)(iii: AEP submits Two FAs re: ILDSA SA No. 1336 to be effective 12/18/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     10/18/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20211018-5074.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 11/8/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER22-129-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Massachusetts Electric Company.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Tariff Amendment: 2020-10-18 Notice of Cancellation of Service Agreement No. CRA-MECO-12 to be effective 12/18/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     10/18/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20211018-5078.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 11/8/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER22-130-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     PJM Interconnection, L.L.C.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: Original ISA, Service Agreement No. 6189; Queue No. AD2-009 to be effective 9/16/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     10/18/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20211018-5089.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 11/8/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER22-131-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Citizens Sunrise Transmission LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: Annual Operating Cost True-Up Adjustment Informational Filing 2021 to be effective 1/1/2022.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     10/18/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20211018-5092.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 11/8/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER22-132-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Citizens Sycamore-Penasquitos Transmission LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: Annual Operating Cost True-Up Adjustment Informational to be effective 1/1/2022.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     10/18/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20211018-5094.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 11/8/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER22-133-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     San Diego Gas &amp; Electric Company.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Informational Filing of Transmission Owner Rate Appendix XII [Cycle 4] of San Diego Gas &amp; Electric Company.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     10/14/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20211014-5173.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 11/4/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER22-134-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     PacifiCorp.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: BPA NITSA—(SE Idaho Area) Rev 7 to be effective 10/1/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     10/18/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20211018-5105.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 11/8/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER22-135-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     PJM Interconnection, L.L.C.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: Revisions to Sch. 12-Appx A: Sept. 2021 RTEP, 30-Day Comment Period Requested to be effective 1/16/2022.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     10/18/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20211018-5127.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 11/8/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER22-136-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Sagebrush Line, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Baseline eTariff Filing: Facilities Use Agreements to be effective 12/20/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     10/18/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20211018-5128.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 11/8/21.
                </P>
                <P>Take notice that the Commission received the following electric securities filings:</P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ES22-12-000; ES22-13-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Delmarva Power &amp; Light Company, Potomac Electric Power Company, Delmarva Power &amp; Light Company, Potomac Electric Power Company.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Application Under Section 204 of the Federal Power Act for Authorization to Issue Securities of Delmarva Power &amp; Light Company, et al.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     10/15/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20211015-5218.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 11/5/21.
                </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: October 18, 2021.</DATED>
                    <NAME>Debbie-Anne A. Reese,</NAME>
                    <TITLE>Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23113 Filed 10-21-21; 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. RM20-10-000; AD19-19-000]</DEPDOC>
                <SUBJECT>Electric Transmission Incentives Policy Under Section 219 of the Federal Power Act; Notice Inviting Post-Workshop Comments</SUBJECT>
                <P>
                    On September 10, 2021, the Federal Energy Regulatory Commission (Commission) staff convened a workshop to discuss certain shared savings incentive approaches that may foster deployment of transmission technologies in the above-captioned dockets.
                    <PRTPAGE P="58650"/>
                </P>
                <P>All interested persons are invited to file post-workshop comments to address the issues raised during the workshop concerning incentives and shared savings. Commenters are also invited to reference material previously filed in this docket but are encouraged to avoid repetition or replication of their previous comments. Comments must be submitted on or before January 14, 2022.</P>
                <P>
                    Comments may be filed electronically via the internet.
                    <SU>1</SU>
                    <FTREF/>
                     Instructions are available on the Commission's website 
                    <E T="03">http://www.ferc.gov/docs-filing/efiling.asp.</E>
                     For assistance, please contact FERC Online Support at 
                    <E T="03">FERCOnlineSupport@ferc.gov</E>
                     or toll free at 1-866-208-3676, or for TTY, (202) 502-8659. Although the Commission strongly encourages electronic filing, documents may also be paper-filed. To paper-file, submissions sent via the U.S. Postal Service must be addressed to: Federal Energy Regulatory Commission, Office of the Secretary, 888 First Street NE, Washington, DC 20426. Submissions sent via any other carrier must be addressed to: Federal Energy Regulatory Commission, Office of the Secretary, 12225 Wilkins Avenue, Rockville, Maryland 20852.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See</E>
                         18 CFR 385.2001(a)(1)(iii) (2020).
                    </P>
                </FTNT>
                <P>For more information about this Notice, please contact:</P>
                <FP SOURCE="FP-1">
                    Samin Peirovi (Technical Information), Office of Energy Policy and Innovation, (202) 502-8080, 
                    <E T="03">Samin.Peirovi@ferc.gov</E>
                </FP>
                <FP SOURCE="FP-1">
                    Meghan O'Brien (Legal Information), Office of the General Counsel, (202) 502-6137, 
                    <E T="03">Meghan.O'Brien@ferc.gov</E>
                </FP>
                <SIG>
                    <DATED>Dated: October 18, 2021.</DATED>
                    <NAME>Debbie-Anne A. Reese,</NAME>
                    <TITLE>Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23112 Filed 10-21-21; 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. CD22-1-000]</DEPDOC>
                <SUBJECT>Larry Lempka; Notice of Preliminary Determination of a Qualifying Conduit Hydropower Facility and Soliciting Comments and Motions To Intervene</SUBJECT>
                <P>On October 14, 2021, Larry Lempka filed a notice of intent to construct a qualifying conduit hydropower facility, pursuant to section 30 of the Federal Power Act (FPA). The proposed Lempka Farms Hydropower Project would have an installed capacity of 5.9 kilowatts (kW), and would be located along an irrigation pipeline on the applicant's property near Berthoud, Larimer County, Colorado.</P>
                <P>
                    <E T="03">Applicant Contact:</E>
                     Timothy Olsen, Advanced Energy Systems, LLC, 1428 S Humboldt St, Denver, CO 80210, (303) 777-3341, 
                    <E T="03">tolsen@windtechnology.com.</E>
                </P>
                <P>
                    <E T="03">FERC Contact:</E>
                     Christopher Chaney, (202) 502-6778, 
                    <E T="03">christopher.chaney@ferc.gov.</E>
                </P>
                <P>
                    <E T="03">Qualifying Conduit Hydropower Facility Description:</E>
                     The proposed project would consist of: (1) An approximately 10-foot by 10-foot powerhouse; (2) one pump-as-turbine unit with a capacity of 5.9 kW; and (3) appurtenant facilities. The proposed project would have an estimated annual generation of approximately 6.7 megawatt-hours.
                </P>
                <P>A qualifying conduit hydropower facility is one that is determined or deemed to meet all the criteria shown in the table below.</P>
                <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s50,r100,xs36">
                    <TTITLE>Table 1—Criteria for Qualifying Conduit Hydropower Facility</TTITLE>
                    <BOXHD>
                        <CHED H="1">Statutory provision</CHED>
                        <CHED H="1">Description</CHED>
                        <CHED H="1">
                            Satisfies
                            <LI>
                                <E T="03">(y/n)</E>
                            </LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">FPA 30(a)(3)(A)</ENT>
                        <ENT>The conduit the facility uses is a tunnel, canal, pipeline, aqueduct, flume, ditch, or similar manmade water conveyance that is operated for the distribution of water for agricultural, municipal, or industrial consumption and not primarily for the generation of electricity</ENT>
                        <ENT>Y</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FPA 30(a)(3)(C)(i)</ENT>
                        <ENT>The facility is constructed, operated, or maintained for the generation of electric power and uses for such generation only the hydroelectric potential of a non-federally owned conduit</ENT>
                        <ENT>Y</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FPA 30(a)(3)(C)(ii)</ENT>
                        <ENT>The facility has an installed capacity that does not exceed 40 megawatts</ENT>
                        <ENT>Y</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FPA 30(a)(3)(C)(iii)</ENT>
                        <ENT>On or before August 9, 2013, the facility is not licensed, or exempted from the licensing requirements of Part I of the FPA</ENT>
                        <ENT>Y</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    <E T="03">Preliminary Determination:</E>
                     The proposed Lempka Farms Hydropower Project will not alter the primary purpose of the conduit, which is used to distribute water for agricultural irrigation. Therefore, based upon the above criteria, Commission staff preliminarily determines that the proposal satisfies the requirements for a qualifying conduit hydropower facility, which is not required to be licensed or exempted from licensing.
                </P>
                <P>
                    <E T="03">Comments and Motions to Intervene:</E>
                     Deadline for filing comments contesting whether the facility meets the qualifying criteria is 30 days from the issuance date of this notice.
                </P>
                <P>Deadline for filing motions to intervene is 30 days from the issuance date of this notice.</P>
                <P>Anyone may submit comments or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210 and 385.214. Any motions to intervene must be received on or before the specified deadline date for the particular proceeding.</P>
                <P>
                    <E T="03">Filing and Service of Responsive Documents:</E>
                     All filings must (1) bear in all capital letters the “COMMENTS CONTESTING QUALIFICATION FOR A CONDUIT HYDROPOWER FACILITY” or “MOTION TO INTERVENE,” as applicable; (2) state in the heading the name of the applicant and the project number of the application to which the filing responds; (3) state the name, address, and telephone number of the person filing; and (4) otherwise comply with the requirements of sections 385.2001 through 385.2005 of the Commission's regulations.
                    <SU>1</SU>
                    <FTREF/>
                     All comments contesting Commission staff's preliminary determination that the facility meets the qualifying criteria must set forth their evidentiary basis.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         18 CFR 385.2001-2005 (2020).
                    </P>
                </FTNT>
                <P>
                    The Commission strongly encourages electronic filing. Please file motions to intervene and 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 
                    <PRTPAGE P="58651"/>
                    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 at 
                    <E T="03">FERCOnlineSupport@ferc.gov,</E>
                     (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, you may send 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, MD 20852. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 385.2010.
                </P>
                <P>
                    <E T="03">Locations of Notice of Intent:</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 website at 
                    <E T="03">http://www.ferc.gov/docs-filing/elibrary.asp.</E>
                     Enter the docket number (
                    <E T="03">i.e.,</E>
                     CD22-1) in the docket number field to access the document. You may also register online at 
                    <E T="03">http://www.ferc.gov/docs-filing/esubscription.asp</E>
                     to be notified via email of new filings and issuances related to this or other pending projects. Copies of the notice of intent can be obtained directly from the applicant. 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, call toll-free 1-866-208-3676 or email 
                    <E T="03">FERCOnlineSupport@ferc.gov.</E>
                     For TTY, call (202) 502-8659.
                </P>
                <SIG>
                    <DATED>Dated: October 18, 2021.</DATED>
                    <NAME>Kimberly D. Bose,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23067 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[EPA-HQ-OPPT-2020-0617; FRL-9167-01-OMS]</DEPDOC>
                <SUBJECT>Information Collection Request Submitted to OMB for Review and Approval; Comment Request; TSCA Mercury Inventory Reporting (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), TSCA Mercury Inventory Reporting (EPA ICR No. 2567.04, OMB Control No. 2070-0207) 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 October 31, 2021. Public comments were previously requested via the 
                        <E T="04">Federal Register</E>
                         on March 24, 2021 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. 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>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Additional comments must be submitted on or before November 22, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit your comments to EPA, referencing Docket ID No. EPA-HQ-OPPT-2020-0617, online using 
                        <E T="03">www.regulations.gov</E>
                         (our preferred method), 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>
                        Thomas Groeneveld, Existing Chemicals Risk Management Division (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 566-1188; email address: 
                        <E T="03">groeneveld.thomas@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    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>
                     As directed in the June 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act amendments to the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 
                    <E T="03">et seq.,</E>
                     EPA is required to assist in the preparation and publication in the 
                    <E T="04">Federal Register</E>
                     of an “inventory of mercury supply, use, and trade in the United States.” 15 U.S.C. 2607(b)(10)(B) and (D). Based on the inventory of information collected through this ICR, the Agency is directed to “identify any manufacturing processes or products that intentionally add mercury” and “recommend actions, including proposed revisions of Federal law or regulations, to achieve further reductions in mercury use.” 15 U.S.C. 2607(b)(10)(C).
                </P>
                <P>The primary purpose of this ICR is to support the development of that inventory. In turn, the inventory will help the Agency identify uses of mercury and recommend means to achieve further reductions of such uses in commerce. In addition, the Agency seeks to obtain the information necessary to achieve its goal to further reduce the use of mercury in products and certain manufacturing processes in order to prevent future releases to the environment, as well as assist the United States in reporting implementation under the Minamata Convention. EPA seeks to enhance its current information on how much mercury is used, in which products and manufacturing processes, and whether certain products are manufactured domestically, imported, or exported.</P>
                <P>
                    Reporting is required from any person who manufactures (including imports) mercury or mercury-added products, as well as any person who otherwise intentionally uses mercury in a 
                    <PRTPAGE P="58652"/>
                    manufacturing process under TSCA Section 8(b). 15 U.S.C. 2607(b)(10)(D)(i). The Agency promulgated reporting under 40 CFR part 713. In order to avoid duplication, EPA coordinated the reporting with the Interstate Mercury Education and Reduction Clearinghouse (IMERC). 15 U.S.C. 2607(b)(10)(D)(ii).
                </P>
                <P>Regulated entities may claim some of the information given to EPA as CBI. Reporting requirements will contain information for respondents on how to make a claim to EPA that all or part of their submitted information is CBI. EPA handles claims of confidentiality pursuant to established CBI procedures, as found in TSCA section 14, 40 CFR part 2, and the Agency's TSCA CBI Manual. CBI is also protected under the Freedom of Information Act (5 U.S.C. 525).</P>
                <P>
                    <E T="03">Form Number:</E>
                     9600-024.
                </P>
                <P>
                    <E T="03">Respondents/affected entities:</E>
                     Persons who manufacture (including import) mercury, mercury-added products, and persons who otherwise intentionally use mercury in a manufacturing process.
                </P>
                <P>
                    <E T="03">Respondent's obligation to respond:</E>
                     Mandatory, 40 CFR part 713.
                </P>
                <P>
                    <E T="03">Estimated number of respondents:</E>
                     756 (total).
                </P>
                <P>
                    <E T="03">Frequency of response:</E>
                     Every three years.
                </P>
                <P>
                    <E T="03">Total estimated burden:</E>
                     17,348 hours (per year). Burden is defined at 5 CFR 1320.3(b).
                </P>
                <P>
                    <E T="03">Total estimated cost:</E>
                     $1,384,999 million (per year), includes no annualized capital or operation &amp; maintenance.
                </P>
                <P>
                    <E T="03">Changes in the estimates:</E>
                     There is a decrease of 6,841 hours per year in the estimated respondent burden compared with the ICR currently approved by OMB. This change reflects a decrease in rule familiarization burden, a decrease in form completion burden due to mercury export prohibitions, and changes in the number of estimated respondents. This change is an adjustment.
                </P>
                <SIG>
                    <NAME>Courtney Kerwin,</NAME>
                    <TITLE>Director, Regulatory Support Division.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23020 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[EPA-HQ-OGC-2021-0725; FRL-9152-01-OGC]</DEPDOC>
                <SUBJECT>Proposed Consent Decree, Clean Air Act Citizen Suit</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed consent decree; request for public comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        In accordance with the Clean Air Act, as amended (CAA or the Act), notice is given of a proposed consent decree in 
                        <E T="03">Our Children's Earth Foundation</E>
                         v. 
                        <E T="03">Regan,</E>
                         No. 20-cv-8530 (N.D. Cal.). On December 2, 2020 and July 9, 2021, Our Children's Earth Foundation filed a complaint and an amended complaint, respectively, in the United States District Court for the Northern District of California, to compel the Administrator to assemble, publish, and publish notice of comprehensive documents setting forth the requirements of the state implementation plans (“SIPs”) for all 50 states of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands (collectively the “States”). The proposed consent decree would establish deadlines for EPA to take specified actions.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Written comments on the proposed consent decree must be received by November 22, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit your comments, identified by Docket ID No. EPA-HQ-OGC-2021-0725, online at
                        <E T="03"> https://www.regulations.gov</E>
                         (EPA's preferred method). Follow the online instructions for submitting comments.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the Docket ID number for this action. Comments received may be posted without change to 
                        <E T="03">https://www.regulations.gov,</E>
                         including any personal information provided. For detailed instructions on sending comments and additional information on the rulemaking process, see the “Additional Information about Commenting on the Proposed Consent Decree” heading under the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section of this document. Out of an abundance of caution for members of the public and our staff, the EPA Docket Center and Reading Room are closed to the public, with limited exceptions, to reduce the risk of transmitting COVID-19. Our Docket Center staff will continue to provide remote customer service via email, phone, and webform. We encourage the public to submit comments via 
                        <E T="03">https://www.regulations.gov,</E>
                         as there may be a delay in processing mail and faxes. Hand deliveries and couriers may be received by scheduled appointment only. For further information on EPA Docket Center services and the current status, please visit us online at 
                        <E T="03">https://www.epa.gov/dockets.</E>
                    </P>
                    <P>EPA continues to carefully and continuously monitor information from the CDC, local area health departments, and our federal partners so that we can respond rapidly as conditions change regarding COVID-19.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Charles Starrs, Air and Radiation Law Office (2344A), Office of General Counsel, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone (202) 564-1996; email address 
                        <E T="03">starrs.charles@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">I. Obtaining a Copy of the Proposed Consent Decree</HD>
                <P>The official public docket for this action (identified by Docket ID No. EPA-HQ-OGC-2021-0725) contains a copy of the proposed consent decree.</P>
                <P>
                    The electronic version of the public docket for this action contains a copy of the proposed consent decree and is available through 
                    <E T="03">https://www.regulations.gov.</E>
                     You may use 
                    <E T="03">https://www.regulations.gov</E>
                     to submit or view public comments, access the index listing of the contents of the official public docket, and access those documents in the public docket that are available electronically. Once in the system, key in the appropriate docket identification number then select “search.”
                </P>
                <HD SOURCE="HD1">II. Additional Information About the Proposed Consent Decree</HD>
                <P>
                    The proposed consent decree would fully resolve 
                    <E T="03">Our Children's Earth Foundation.</E>
                     v. 
                    <E T="03">Regan,</E>
                     No. 20-cv-8530 (N.D. CA.) (the Litigation). The Litigation claimed that CAA section 110(h)(1) required EPA to periodically publish comprehensive documents setting out the States' SIP requirements and also required EPA to periodically publish notice in the 
                    <E T="04">Federal Register</E>
                     of the availability of such documents. The Litigation also claimed that EPA had failed to comply with the requirements of CAA section 110(h)(1). Under the terms of the proposed consent decree, no later than December 31, 2021, EPA will assemble and publish online on EPA-managed or controlled websites the “SIP Rules” for all States, except for California, Connecticut, North Carolina, Wisconsin, Puerto Rico, and the U.S. Virgin Islands. The information published by that date will include SIP Rule revisions and submittals finally approved by EPA and published in the 
                    <E T="04">Federal Register</E>
                     on or before November 30, 2021. In addition, under the terms of the proposed consent decree, no later than September 30, 2022, EPA will 
                    <PRTPAGE P="58653"/>
                    assemble and publish online on EPA-managed or controlled websites the SIP Rules, including SIP Rule revisions and submittals finally approved by EPA and published in the 
                    <E T="04">Federal Register</E>
                     on or before August 31, 2022, for every State. The proposed consent decree does not require EPA to publish “SIP Plans,” consisting of various nonregulatory or quasi-regulatory plans or material, as distinct from SIP Rules. The proposed consent decree also provides that, not later than November 30, 2022, EPA shall submit to the Office of the Federal Register, for publication in the 
                    <E T="04">Federal Register</E>
                    , a notice of availability of the SIP Rules information published by EPA on EPA-managed or controlled websites. See the proposed consent decree in the docket for other terms and conditions.
                </P>
                <P>In accordance with section 113(g) of the CAA, for a period of thirty (30) days following the date of publication of this document, the Agency will accept written comments relating to the proposed consent decree. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the Act.</P>
                <HD SOURCE="HD1">III. Additional Information About Commenting on the Proposed Consent Decree</HD>
                <P>
                    Submit your comments, identified by Docket ID No. EPA-HQ-OGC-2021-0725, via 
                    <E T="03">https://www.regulations.gov.</E>
                     Once submitted, comments cannot be edited or removed from this docket. EPA may publish any comment received to its public docket. Do not submit to EPA's docket at 
                    <E T="03">https://www.regulations.gov</E>
                     any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (
                    <E T="03">i.e.,</E>
                     on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit 
                    <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets.</E>
                     For additional information about submitting information identified as CBI, please contact the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section of this document. Note that written comments containing CBI and submitted by mail may be delayed and deliveries or couriers will be received by scheduled appointment only.
                </P>
                <P>If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.</P>
                <P>
                    Use of the 
                    <E T="03">https://www.regulations.gov</E>
                     website to submit comments to EPA electronically is EPA's preferred method for receiving comments. The electronic public docket system is an “anonymous access” system, which means EPA will not know your identity, email address, or other contact information unless you provide it in the body of your comment.
                </P>
                <P>Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.</P>
                <SIG>
                    <NAME>Gautam Srinivasan,</NAME>
                    <TITLE>Associate General Counsel.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23042 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[EPA-HQ-OPPT-2020-0616; FRL-9173-01-OMS]</DEPDOC>
                <SUBJECT>Information Collection Request Submitted to OMB for Review and Approval; Comment Request; User Fees for the Administration of the Toxic Substances Control Act (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), User Fees for the Administration of the Toxic Substances Control Act (EPA ICR Number 2569.04, OMB Control Number 2070-0208) 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 October 31, 2021. Public comments were previously requested via the 
                        <E T="04">Federal Register</E>
                         on March 19, 2021 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. 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>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Additional comments may be submitted on or before November 22, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit your comments to EPA, referencing Docket ID No. EPA-HQ-OPPT-2020-0616, online using 
                        <E T="03">www.regulations.gov</E>
                         (our preferred method), by email to 
                        <E T="03">sleasman.katherine@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>
                        Marc Edmonds, Existing Chemicals Risk Management Division (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 566-0758; email address: 
                        <E T="03">edmonds.marc@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Supporting documents, which explain in detail the information that the EPA 
                    <PRTPAGE P="58654"/>
                    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>
                     The Frank R. Lautenberg Chemical Safety for the 21st Century Act of 2016 made transformative changes to the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 
                    <E T="03">et seq.,</E>
                     including an amendment that provides EPA with the authority to collect fees to defray 25% of the costs associated with administering TSCA sections 4, 5 and 6, as well as the costs of collecting, processing, reviewing and providing access to and protecting CBI from disclosure as appropriate under TSCA section 14. Payments are required from manufacturers (defined by statute to include importers) of a chemical substance who are required to submit information to EPA under TSCA section 4: Who submit certain notices and exemption requests to EPA under TSCA section 5: Who manufacture a chemical substance that is subject to a risk evaluation under TSCA section 6(b)(4): And who process a chemical substance that is the subject of a Significant New Use Notice (SNUN) or Test Market Exemption (TME) under TSCA section 5 and are required to submit information to EPA under TSCA section 4 related to a SNUN submission. EPA is not collecting a fee for submissions of Confidential Business Information (CBI) submitted under TSCA section 14.
                </P>
                <P>
                    These fees are intended to achieve the goals articulated by Congress to provide a sustainable source of funds for EPA to fulfill its legal obligations to conduct the activities required under TSCA sections 4, 5 and 6 (such as risk-based screenings, designation of applicable substances as High- and Low-Priority, conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, requiring testing of chemical substances and mixtures, and evaluating and reviewing manufacturing and processing notices), as well as the activities under TSCA section 14 (
                    <E T="03">i.e.,</E>
                     collecting, processing, reviewing, and providing access to and protecting information about chemical substances from disclosure as appropriate).
                </P>
                <P>
                    <E T="03">Form Numbers:</E>
                     9600-008.
                </P>
                <P>
                    <E T="03">Respondents/Affected Entities:</E>
                     Entities identified by the following North American Industrial Classification System (NAICS) codes:
                </P>
                <P>• Petroleum and Coal Products (NAICS code 324);</P>
                <P>• Chemical Manufacturing (NAICS code 325); and</P>
                <P>• Chemical, Petroleum and Merchant Wholesalers (NAICS code 424).</P>
                <P>
                    <E T="03">Respondent's obligation to respond:</E>
                     Mandatory, TSCA Section 26(b).
                </P>
                <P>
                    <E T="03">Estimated number of respondents:</E>
                     1,348 (total).
                </P>
                <P>
                    <E T="03">Frequency of response:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Total estimated burden:</E>
                     598 hours (per year). Burden is defined at 5 CFR 1320.3(b).
                </P>
                <P>
                    <E T="03">Total estimated cost:</E>
                     $46,906 (per year), includes $0 annualized capital or operation &amp; maintenance costs.
                </P>
                <P>
                    <E T="03">Changes in the estimates:</E>
                     There is an increase in the total estimated respondent burden compared with the ICR currently approved by OMB due to the increase in the number of entities potentially affected and an increase in the number of information collection activities. The change reflects the number of submissions received under TSCA sections 5 and 6. EPA's burden estimates for this collection are based upon historical information on the number of chemicals per premanufacture notices (PMNs), significant new use notifications (SNUNs), microbial commercial activity notices (MCANs), and exemption notices and applications including low-volume exemptions (LVEs), test-marketing exemptions (TMEs), low exposure/low release exemptions (LoREXs), TSCA experimental release applications (TERAs), certain new microorganism (Tier II) exemptions, and film article exemptions., and actions under TSCA section 6. This change is an adjustment.
                </P>
                <SIG>
                    <NAME>Courtney Kerwin,</NAME>
                    <TITLE>Director, Regulatory Support Division.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23025 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY </AGENCY>
                <DEPDOC>[ER-FRL-9058-9] </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) Filed October 8, 2021 10 a.m. EST Through October 18, 2021 10 a.m. EST Pursuant to 40 CFR 1506.9.</FP>
                <FP SOURCE="FP-1">
                    <E T="03">Notice:</E>
                     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://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.</E>
                </FP>
                <FP SOURCE="FP-1">
                    <E T="03">EIS No. 20210155, Draft, RUS, OK,</E>
                     Skeleton Creek Solar and Battery Storage Project, Garfield County, Oklahoma, 
                    <E T="03">Comment Period Ends:</E>
                     12/06/2021, 
                    <E T="03">Contact:</E>
                     Kristen Bastis 202-692-4910.
                </FP>
                <FP SOURCE="FP-1">
                    <E T="03">EIS No. 20210156, Draft, USFS, BLM, ID,</E>
                     Husky 1 North Dry Ridge Phosphate Mine, 
                    <E T="03">Comment Period Ends:</E>
                     12/06/2021, 
                    <E T="03">Contact:</E>
                     Wes Gilmer 208-478-6369.
                </FP>
                <HD SOURCE="HD1">Amended Notice</HD>
                <FP SOURCE="FP-1">
                    <E T="03">EIS No. 20210135, Draft, USFS, MN,</E>
                     Lutsen Mountains Ski Area Expansion Project, 
                    <E T="03">Comment Period Ends:</E>
                     12/09/2021, 
                    <E T="03">Contact:</E>
                     Michael Jimenez 218-626-4383. Revision to FR Notice Published 09/10/2021; Extending the Comment Period from 10/25/2021 to 12/09/2021.
                </FP>
                <SIG>
                    <DATED>Dated: October 18, 2021.</DATED>
                    <NAME>Cindy S. Barger,</NAME>
                    <TITLE>Director, NEPA Compliance Division, Office of Federal Activities. </TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23057 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[EPA-HQ-OPP-2017-0750; FRL-9079-01-OCSPP]</DEPDOC>
                <SUBJECT>Pesticide Registration Review; Proposed Interim Decisions for Several Pesticides; Notice of Availability</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice announces the availability of EPA's proposed interim registration review decisions and opens a 60-day public comment period on the proposed interim decisions for the following pesticides: Chlormequat chloride; cycloate; famoxadone, inorganic chlorates, napropamide, nicarbazin, pyridalyl, and tetraconazole.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before December 21, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit your comments, identified by the docket identification (ID) number for the specific pesticide of interest provided in the Table in Unit IV., using the 
                        <E T="03">Federal eRulemaking Portal</E>
                         at 
                        <E T="03">http://www.regulations.gov.</E>
                         Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business 
                        <PRTPAGE P="58655"/>
                        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">http://www.epa.gov/dockets.</E>
                    </P>
                    <P>
                        Due to the public health concerns related to COVID-19, the EPA/DC and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on the EPA/DC and docket access, visit 
                        <E T="03">https://www.epa.gov/dockets.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P/>
                    <P>
                        <E T="03">For pesticide specific information, contact:</E>
                         The Chemical Review Manager for the pesticide of interest identified in the Table in Unit IV.
                    </P>
                    <P>
                        <E T="03">For general information on the registration review program, contact:</E>
                         Melanie Biscoe, Pesticide Re-Evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (703) 305-7106; email address: 
                        <E T="03">biscoe.melanie@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. General Information</HD>
                <HD SOURCE="HD2">A. Does this action apply to me?</HD>
                <P>This action is directed to the public in general and may be of interest to a wide range of stakeholders including environmental, human health, farm worker, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the Chemical Review Manager for the pesticide of interest identified in the Table in Unit IV.</P>
                <HD SOURCE="HD2">B. What should I consider as I prepare my comments for EPA?</HD>
                <P>
                    1. 
                    <E T="03">Submitting CBI.</E>
                     Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information on a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
                </P>
                <P>
                    2. 
                    <E T="03">Tips for preparing your comments.</E>
                     When preparing and submitting your comments, see the commenting tips at 
                    <E T="03">http://www.epa.gov/dockets/comments.html.</E>
                </P>
                <P>
                    3. 
                    <E T="03">Environmental justice.</E>
                     EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low-income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticides discussed in this document, compared to the general population.
                </P>
                <HD SOURCE="HD1">II. Background</HD>
                <P>Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. As part of the registration review process, the Agency has completed proposed interim decisions for all pesticides listed in the Table in Unit IV. Through this program, EPA is ensuring that each pesticide's registration is based on current scientific and other knowledge, including its effects on human health and the environment.</P>
                <HD SOURCE="HD1">III. Authority</HD>
                <P>EPA is conducting its registration review of the chemicals listed in the Table in Unit IV pursuant to section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural Regulations for Registration Review at 40 CFR part 155, subpart C. Section 3(g) of FIFRA provides, among other things, that the registrations of pesticides are to be reviewed every 15 years. Under FIFRA, a pesticide product may be registered or remain registered only if it meets the statutory standard for registration given in FIFRA section 3(c)(5) (7 U.S.C. 136a(c)(5)). When used in accordance with widespread and commonly recognized practice, the pesticide product must perform its intended function without unreasonable adverse effects on the environment; that is, without any unreasonable risk to man or the environment, or a human dietary risk from residues that result from the use of a pesticide in or on food.</P>
                <HD SOURCE="HD1">IV. What action is the Agency taking?</HD>
                <P>Pursuant to 40 CFR 155.58, this notice announces the availability of EPA's proposed interim registration review decisions for the pesticides shown in Table 1 and opens a 60-day public comment period on the proposed interim registration review decisions.</P>
                <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s50,r75,r100">
                    <TTITLE>Table 1—Proposed Interim Decisions</TTITLE>
                    <BOXHD>
                        <CHED H="1">Registration review case name and No.</CHED>
                        <CHED H="1">Docket ID No.</CHED>
                        <CHED H="1">Chemical review manager and contact information</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Chlormequat chloride, Case Number 7069</ENT>
                        <ENT>EPA-HQ-OPP-2015-0816</ENT>
                        <ENT>
                            Rachel Stephenson, 
                            <E T="03">stephenson.rachel@epa.gov,</E>
                             (703) 347-8904.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Cycloate, Case Number 2125</ENT>
                        <ENT>EPA-HQ-OPP-2015-0288</ENT>
                        <ENT>
                            Robert Little, 
                            <E T="03">little.robert@epa.gov,</E>
                             (703) 347-8156.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Famoxadone, Case Number 7038</ENT>
                        <ENT>EPA-HQ-OPP-2015-0094</ENT>
                        <ENT>
                            Christina Scheltema, 
                            <E T="03">scheltema.christina@epa.gov,</E>
                             (703) 308-2201.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Inorganic Chlorates, Case Number 4049</ENT>
                        <ENT>EPA-HQ-OPP-2016-0080</ENT>
                        <ENT>
                            Ana Pinto, 
                            <E T="03">pinto.ana@epa.gov,</E>
                             (703) 347-8421.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Napropamide, Case Number 2450</ENT>
                        <ENT>EPA-HQ-OPP-2016-0019</ENT>
                        <ENT>
                            Carolyn Smith, 
                            <E T="03">smith.carolyn@epa.gov,</E>
                             (703) 347-8325.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Nicarbazin, Case Number 7628</ENT>
                        <ENT>EPA-HQ-OPP-2015-0101</ENT>
                        <ENT>
                            Samantha Thomas, 
                            <E T="03">thomas.samantha@epa.gov,</E>
                             (703) 347-0514.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Pyridalyl, Case Number 7451</ENT>
                        <ENT>EPA-HQ-OPP-2019-0378</ENT>
                        <ENT>
                            Rachel Eberius, 
                            <E T="03">eberius.rachel@epa.gov,</E>
                             (703) 347-0492.
                        </ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="58656"/>
                        <ENT I="01">Tetraconazole, Case Number 7043</ENT>
                        <ENT>EPA-HQ-OPP-2015-0061</ENT>
                        <ENT>
                            Veronica Dutch, 
                            <E T="03">dutch.veronica@epa.gov,</E>
                             (703) 308-8585.
                        </ENT>
                    </ROW>
                </GPOTABLE>
                <P>The registration review docket for a pesticide includes earlier documents related to the registration review case. For example, the review opened with a Preliminary Work Plan, for public comment. A Final Work Plan was placed in the docket following public comment on the Preliminary Work Plan.</P>
                <P>The documents in the dockets describe EPA's rationales for conducting additional risk assessments for the registration review of the pesticides included in the tables in Unit IV, as well as the Agency's subsequent risk findings and consideration of possible risk mitigation measures. These proposed interim registration review decisions are supported by the rationales included in those documents. Following public comment, the Agency will issue interim or final registration review decisions for the pesticides listed in Table 1 in Unit IV.</P>
                <P>
                    The registration review final rule at 40 CFR 155.58(a) provides for a minimum 60-day public comment period on all proposed interim registration review decisions. This comment period is intended to provide an opportunity for public input and a mechanism for initiating any necessary amendments to the proposed interim decision. All comments should be submitted using the methods in 
                    <E T="02">ADDRESSES</E>
                     and must be received by EPA on or before the closing date. These comments will become part of the docket for the pesticides included in the Tables in Unit IV. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.
                </P>
                <P>The Agency will carefully consider all comments received by the closing date and may provide a “Response to Comments Memorandum” in the docket. The interim registration review decision will explain the effect that any comments had on the interim decision and provide the Agency's response to significant comments.</P>
                <P>
                    Background on the registration review program is provided at: 
                    <E T="03">http://www.epa.gov/pesticide-reevaluation.</E>
                </P>
                <EXTRACT>
                    <FP>
                        (Authority: 7 U.S.C. 136 
                        <E T="03">et seq.</E>
                        )
                    </FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: October 18, 2021.</DATED>
                    <NAME>Mary Elissa Reaves,</NAME>
                    <TITLE>Director, Pesticide Re-Evaluation Division, Office of Pesticide Programs.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23043 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[EPA-HQ-OPP-2017-0751; FRL-9076-01-OCSPP]</DEPDOC>
                <SUBJECT>Pesticide Registration Review; Interim Decisions and Case Closures for Several Pesticides; Notice of Availability</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice announces the availability of EPA's interim registration review decisions for the following chemicals: Amicarbazone; aminopyralid; azadirachtin, cold pressed neem oil and clarified hydrophobic neem oil; benzoic acid; endothall and salts; ethofumesate; fluoxastrobin; forchlorfenuron; gamma-cyhalothrin; inorganic halides; ipconazole; L-lactic acid; lambda-cyhalothrin; metam/MITC; metconazole; myclobutanil; novaluron; picloram; prometon; prothioconazole; and pyrasulfotole. In addition, it announces the closure of the registration review case for propazine.</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        <E T="03">For pesticide specific information, contact:</E>
                         The Chemical Review Manager for the pesticide of interest identified in the Table in Unit IV.
                    </P>
                    <P>
                        <E T="03">For general information on the registration review program, contact:</E>
                         Melanie Biscoe, Pesticide Re-evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (703) 305-7106; email address: 
                        <E T="03">biscoe.melanie@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. General Information</HD>
                <HD SOURCE="HD2">A. Does this action apply to me?</HD>
                <P>This action is directed to the public in general and may be of interest to a wide range of stakeholders including environmental, human health, farm worker, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the pesticide specific contact person listed in the Table in Unit IV.</P>
                <HD SOURCE="HD2">B. How can I get copies of this document and other related information?</HD>
                <P>
                    The dockets these cases, identified by the docket identification (ID) number for the specific pesticide of interest provided in the Table in Unit IV., are available at 
                    <E T="03">http://www.regulations.gov</E>
                     or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805.
                </P>
                <P>
                    Due to the public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit 
                    <E T="03">https://www.epa.gov/dockets.</E>
                </P>
                <HD SOURCE="HD1">II. Background</HD>
                <P>
                    Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. As part of the registration review process, the Agency has completed interim decisions for all pesticides listed in the Table in Unit IV. Through this program, EPA is ensuring that each pesticide's 
                    <PRTPAGE P="58657"/>
                    registration is based on current scientific and other knowledge, including its effects on human health and the environment.
                </P>
                <HD SOURCE="HD1">III. Authority</HD>
                <P>EPA is conducting its registration review of the chemicals listed in the Table in Unit IV pursuant to section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural Regulations for Registration Review at 40 CFR part 155, subpart C. Section 3(g) of FIFRA provides, among other things, that the registrations of pesticides are to be reviewed every 15 years. Under FIFRA, a pesticide product may be registered or remain registered only if it meets the statutory standard for registration given in FIFRA section 3(c)(5) (7 U.S.C. 136a(c)(5)). When used in accordance with widespread and commonly recognized practice, the pesticide product must perform its intended function without unreasonable adverse effects on the environment; that is, without any unreasonable risk to man or the environment, or a human dietary risk from residues that result from the use of a pesticide in or on food.</P>
                <HD SOURCE="HD1">IV. What action is the Agency taking?</HD>
                <P>Pursuant to 40 CFR 155.58, this notice announces the availability of EPA's interim registration review decisions for the pesticides shown in the following table. The interim registration review decisions are supported by rationales included in the docket established for each chemical.</P>
                <GPOTABLE COLS="3" OPTS="L2,nj,i1" CDEF="s50,xls100,r50">
                    <TTITLE>Table—Registration Review Interim Decisions Being Issued</TTITLE>
                    <BOXHD>
                        <CHED H="1">Registration review case name and No.</CHED>
                        <CHED H="1">Docket ID No.</CHED>
                        <CHED H="1">Chemical review manager and contact information</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Amicarbazone, Case Number 7262</ENT>
                        <ENT>EPA-HQ-OPP-2015-0400</ENT>
                        <ENT>
                            Samantha Thomas, 
                            <E T="03">thomas.samantha@epa.gov</E>
                            , (703) 347-0514.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Aminopyralid, Case Number 7267</ENT>
                        <ENT>EPA-HQ-OPP-2013-0749</ENT>
                        <ENT>
                            Rachel Stephenson, 
                            <E T="03">stephenson.rachel@epa.gov</E>
                            , (703) 347-8904.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Azadirachtin, Cold Pressed Neem Oil, and Clarified Hydrophobic Neem Oil, Case Number 6021</ENT>
                        <ENT>EPA-HQ-OPP-2008-0632</ENT>
                        <ENT>
                            Joseph Mabon, 
                            <E T="03">mabon.joseph@epa.gov</E>
                            , (703) 347-0177.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Benzoic Acid, Case Number 5107</ENT>
                        <ENT>EPA-HQ-OPP-2010-0692</ENT>
                        <ENT>
                            Megan Snyderman, 
                            <E T="03">snyderman.megan@epa.gov</E>
                            , (703) 347-0671.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Endothall and Salts, Case Number 2245</ENT>
                        <ENT>EPA-HQ-OPP-2015-0591</ENT>
                        <ENT>
                            Robert Little, 
                            <E T="03">little.robert@epa.gov</E>
                            , (703) 347-8156.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Ethofumesate, Case Number 2265</ENT>
                        <ENT>EPA-HQ-OPP-2015-0406</ENT>
                        <ENT>
                            James Douglass, 
                            <E T="03">douglass.james@epa.gov</E>
                            , (703) 347-8630.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Fluoxastrobin, Case Number 7044</ENT>
                        <ENT>EPA-HQ-OPP-2015-0295</ENT>
                        <ENT>
                            Rachel Fletcher, 
                            <E T="03">fletcher.rachel@epa.gov</E>
                            , (703) 347-0512.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Forchlorfenuron, Case Number 7057</ENT>
                        <ENT>EPA-HQ-OPP-2014-0641</ENT>
                        <ENT>
                            Srijana Shrestha, 
                            <E T="03">shrestha.srijana@epa.gov</E>
                            , (703) 305-6471.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Gamma-cyhalothrin, Case Number 7437</ENT>
                        <ENT>EPA-HQ-OPP-2010-0479</ENT>
                        <ENT>
                            Darius Stanton, 
                            <E T="03">stanton.darius@epa.gov</E>
                            , (703) 347-0433.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Inorganic halides, Case Number 4051</ENT>
                        <ENT>EPA-HQ-OPP-2009-0168</ENT>
                        <ENT>
                            Erin Dandridge, 
                            <E T="03">dandridge.erin@epa.gov</E>
                            , (703) 347-0185.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Ipconazole, Case Number 7041</ENT>
                        <ENT>EPA-HQ-OPP-2015-0590</ENT>
                        <ENT>
                            Alex Hazlehurst, 
                            <E T="03">hazlehurst.alexander@epa.gov</E>
                            , (703) 347-0221.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">L-lactic Acid, Case Number 6062</ENT>
                        <ENT>EPA-HQ-OPP-2020-0552</ENT>
                        <ENT>
                            SanYvette Williams, 
                            <E T="03">williams.sanyvette@epa.gov</E>
                            , (703) 305-7702.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Lambda-cyhalothrin, Case number 7408</ENT>
                        <ENT>EPA-HQ-OPP-2010-0480</ENT>
                        <ENT>
                            Darius Stanton, 
                            <E T="03">stanton.darius@epa.gov</E>
                            , (703) 347-0433.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Metam/MITC, Case Number 2390 &amp; 2405</ENT>
                        <ENT>EPA-HQ-OPP-2013-0140 &amp; EPA-HQ-OPP-2013-0242</ENT>
                        <ENT>
                            Tiffany Green, 
                            <E T="03">green.tiffany@epa.gov</E>
                            , (703) 347-0314.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Metconazole, Case Number 7049</ENT>
                        <ENT>EPA-HQ-OPP-2015-0013</ENT>
                        <ENT>
                            Samantha Thomas, 
                            <E T="03">thomas.samantha@epa.gov</E>
                            , (703) 347-0514.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Myclobutanil, Case Number 7006</ENT>
                        <ENT>EPA-HQ-OPP-2015-0053</ENT>
                        <ENT>
                            Anitha Kisanga, 
                            <E T="03">kisanga.anitha@epa.gov</E>
                            , (703) 347-0540.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Novaluron Case Number 7615 </ENT>
                        <ENT>EPA-HQ-OPP-2015-0171</ENT>
                        <ENT>
                            Robert Little, 
                            <E T="03">little.robert@epa.gov</E>
                            , (703) 347-8156.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Picloram, Case Number 0096</ENT>
                        <ENT>EPA-HQ-OPP-2013-0740 </ENT>
                        <ENT>
                            Andy Muench, 
                            <E T="03">muench.andrew@epa.gov</E>
                            , (703) 347-8263.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Prometon, Case Number 2545</ENT>
                        <ENT>EPA-HQ-OPP-2013-0068</ENT>
                        <ENT>
                            Carolyn Smith, 
                            <E T="03">smith.carolyn@epa.gov</E>
                            , (703) 347-8325.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Prothioconazole, Case Number 7054</ENT>
                        <ENT>EPA-HQ-OPP-2015-0474</ENT>
                        <ENT>
                            Rachel Eberius, 
                            <E T="03">eberius.rachel@epa.gov</E>
                            , (703) 347-0492.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Pyrasulfotole, Case Number 7272</ENT>
                        <ENT>EPA-HQ-OPP-2016-0391</ENT>
                        <ENT>
                            James Douglass, 
                            <E T="03">douglass.james@epa.gov</E>
                            , (703) 347-8630.
                        </ENT>
                    </ROW>
                </GPOTABLE>
                <P>The proposed interim registration review decisions for the chemicals in the table above were posted to the docket and the public was invited to submit any comments or new information. EPA addressed the comments or information received during the 60-day comment period for the proposed interim decisions in the discussion for each pesticide listed in the table. Comments from the 60-day comment period that were received may or may not have affected the Agency's interim decision. Pursuant to 40 CFR 155.58(c), the registration review case docket for the chemicals listed in the Table will remain open until all actions required in the interim decision have been completed.</P>
                <P>This document also announces the closure of the registration review case for propazine (Case Number 0230, Docket ID Number EPA-HQ-OPP-2013-0250) because the last U.S. registrations for these pesticides have been canceled.</P>
                <P>
                    Background on the registration review program is provided at: 
                    <E T="03">http://www.epa.gov/pesticide-reevaluation.</E>
                </P>
                <EXTRACT>
                    <PRTPAGE P="58658"/>
                    <FP>
                        (Authority: 7 U.S.C. 136 
                        <E T="03">et seq.</E>
                        )
                    </FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: October 18, 2021.</DATED>
                    <NAME>Mary Elissa Reaves,</NAME>
                    <TITLE>Director, Pesticide Re-Evaluation Division, Office of Pesticide Programs.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23041 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[EPA-HQ-OPPT-2021-0068; FRL-8732-04-OCSPP]</DEPDOC>
                <SUBJECT>Certain New Chemicals; Receipt and Status Information for September 2021</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>
                        EPA is required under the Toxic Substances Control Act (TSCA) to make information publicly available and to publish information in the 
                        <E T="04">Federal Register</E>
                         pertaining to submissions under TSCA Section 5, including notice of receipt of a Premanufacture notice (PMN), Significant New Use Notice (SNUN) or Microbial Commercial Activity Notice (MCAN), including an amended notice or test information; an exemption application (Biotech exemption); an application for a test marketing exemption (TME), both pending and/or concluded; a notice of commencement (NOC) of manufacture (including import) for new chemical substances; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. This document covers the period from 09/01/2021 to 09/30/2021.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments identified by the specific case number provided in this document must be received on or before November 22, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2021-0068, and the specific case number for the chemical substance related to your comment, through the Federal eRulemaking Portal at 
                        <E T="03">http://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">http://www.epa.gov/dockets.</E>
                    </P>
                    <P>
                        Due to the public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit 
                        <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>
                         Jim Rahai, Project Management and Operations Division (MC 7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-8593; email address: 
                        <E T="03">rahai.jim@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>
                <HD SOURCE="HD1">I. Executive Summary</HD>
                <HD SOURCE="HD2">A. What action is the Agency taking?</HD>
                <P>This document provides the receipt and status reports for the period from 09/01/2021 to 09/30/2021. The Agency is providing notice of receipt of PMNs, SNUNs and MCANs (including amended notices and test information); an exemption application under 40 CFR part 725 (Biotech exemption); TMEs, both pending and/or concluded; NOCs to manufacture a new chemical substance; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review.</P>
                <P>
                    EPA is also providing information on its website about cases reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN and exemption notices received, the date of receipt, the final EPA determination on the notice, and the effective date of EPA's determination for PMN/SNUN/MCAN notices on its website at: 
                    <E T="03">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices.</E>
                     This information is updated on a weekly basis.
                </P>
                <HD SOURCE="HD2">B. What is the Agency's authority for taking this action?</HD>
                <P>
                    Under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 
                    <E T="03">et seq.,</E>
                     a chemical substance may be either an “existing” chemical substance or a “new” chemical substance. Any chemical substance that is not on EPA's TSCA Inventory of Chemical Substances (TSCA Inventory) is classified as a “new chemical substance,” while a chemical substance that is listed on the TSCA Inventory is classified as an “existing chemical substance.” (See TSCA section 3(11).) For more information about the TSCA Inventory please go to: 
                    <E T="03">https://www.epa.gov/tsca-inventory</E>
                    .
                </P>
                <P>Any person who intends to manufacture (including import) a new chemical substance for a non-exempt commercial purpose, or to manufacture or process a chemical substance in a non-exempt manner for a use that EPA has determined is a significant new use, is required by TSCA section 5 to provide EPA with a PMN, MCAN or SNUN, as appropriate, before initiating the activity. EPA will review the notice, make a risk determination on the chemical substance or significant new use, and take appropriate action as described in TSCA section 5(a)(3).</P>
                <P>
                    TSCA section 5(h)(1) authorizes EPA to allow persons, upon application and under appropriate restrictions, to manufacture or process a new chemical substance, or a chemical substance subject to a significant new use rule (SNUR) issued under TSCA section 5(a)(2), for “test marketing” purposes, upon a showing that the manufacture, processing, distribution in commerce, use, and disposal of the chemical will not present an unreasonable risk of injury to health or the environment. This is referred to as a test marketing exemption, or TME. For more information about the requirements applicable to a new chemical go to: 
                    <E T="03">http://www.epa.gov/oppt/newchems</E>
                    .
                </P>
                <P>
                    Under TSCA sections 5 and 8 and EPA regulations, EPA is required to publish in the 
                    <E T="04">Federal Register</E>
                     certain information, including notice of receipt of a PMN/SNUN/MCAN (including amended notices and test information); an exemption application under 40 CFR part 725 (biotech exemption); an application for a TME, both pending and concluded; NOCs to manufacture a new chemical substance; and a periodic status report on the new chemical substances that are currently under EPA review or have recently concluded review.
                </P>
                <HD SOURCE="HD2">C. Does this action apply to me?</HD>
                <P>This action provides information that is directed to the public in general.</P>
                <HD SOURCE="HD2">D. Does this action have any incremental economic impacts or paperwork burdens?</HD>
                <P>No.</P>
                <HD SOURCE="HD2">E. What should I consider as I prepare my comments for EPA?</HD>
                <P>
                    1. 
                    <E T="03">Submitting confidential business information (CBI).</E>
                     Do not submit this information to EPA through 
                    <PRTPAGE P="58659"/>
                    <E T="03">regulations.gov</E>
                     or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
                </P>
                <P>
                    2. 
                    <E T="03">Tips for preparing your comments.</E>
                     When preparing and submitting your comments, see the commenting tips at 
                    <E T="03">http://www.epa.gov/dockets/comments.html.</E>
                </P>
                <HD SOURCE="HD1">II. Status Reports</HD>
                <P>
                    In the past, EPA has published individual notices reflecting the status of TSCA section 5 filings received, pending or concluded. In 1995, the Agency modified its approach and streamlined the information published in the 
                    <E T="04">Federal Register</E>
                     after providing notice of such changes to the public and an opportunity to comment (See the 
                    <E T="04">Federal Register</E>
                     of May 12, 1995, (60 FR 25798) (FRL-4942-7). Since the passage of the Lautenberg amendments to TSCA in 2016, public interest in information on the status of section 5 cases under EPA review and, in particular, the final determination of such cases, has increased. In an effort to be responsive to the regulated community, the users of this information, and the general public, to comply with the requirements of TSCA, to conserve EPA resources and to streamline the process and make it more timely, EPA is providing information on its website about cases reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN and exemption notices received, the date of receipt, the final EPA determination on the notice, and the effective date of EPA's determination for PMN/SNUN/MCAN notices on its website at: 
                    <E T="03">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices.</E>
                     This information is updated on a weekly basis.
                </P>
                <HD SOURCE="HD1">III. Receipt Reports</HD>
                <P>
                    For the PMN/SNUN/MCANs that have passed an initial screening by EPA during this period, Table I provides the following information (to the extent that such information is not subject to a CBI claim) on the notices screened by EPA during this period: The EPA case number assigned to the notice that indicates whether the submission is an initial submission, or an amendment, a notation of which version was received, the date the notice was received by EPA, the submitting manufacturer (
                    <E T="03">i.e.,</E>
                     domestic producer or importer), the potential uses identified by the manufacturer in the notice, and the chemical substance identity.
                </P>
                <P>
                    As used in each of the tables in this unit, (S) indicates that the information in the table is the specific information provided by the submitter, and (G) indicates that this information in the table is generic information because the specific information provided by the submitter was claimed as CBI. Submissions which are initial submissions will not have a letter following the case number. Submissions which are amendments to previous submissions will have a case number followed by the letter “A” (
                    <E T="03">e.g.,</E>
                     P-18-1234A). The version column designates submissions in sequence as “1”, “2”, “3”, etc. Note that in some cases, an initial submission is not numbered as version 1; this is because earlier version(s) were rejected as incomplete or invalid submissions. Note also that future versions of the following tables may adjust slightly as the Agency works to automate population of the data in the tables.
                </P>
                <GPOTABLE COLS="6" OPTS="L2,nj,i1" CDEF="s50,10,12,r50,r100,r100">
                    <TTITLE>Table I—PMN/SNUN/MCANs Approved * From 09/01/2021 to 09/30/2021</TTITLE>
                    <BOXHD>
                        <CHED H="1">Case No.</CHED>
                        <CHED H="1">Version</CHED>
                        <CHED H="1">Received date</CHED>
                        <CHED H="1">Manufacturer</CHED>
                        <CHED H="1">Use</CHED>
                        <CHED H="1">Chemical substance</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">P-18-0049A</ENT>
                        <ENT>8</ENT>
                        <ENT>09/28/2021</ENT>
                        <ENT>Solvay Fluorides LLC</ENT>
                        <ENT>(G) Coating component/processing aid</ENT>
                        <ENT>(G) Mixed metal halide.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-18-0128A</ENT>
                        <ENT>6</ENT>
                        <ENT>09/14/2021</ENT>
                        <ENT>CBI</ENT>
                        <ENT>(G) Surface modifier</ENT>
                        <ENT>(S) Inulin, 2-hydroxy-3-(trimethylammonio)propyl ether, chloride.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-20-0018A</ENT>
                        <ENT>4</ENT>
                        <ENT>09/24/2021</ENT>
                        <ENT>CBI</ENT>
                        <ENT>(G) Component in candles</ENT>
                        <ENT>(G) Fatty acid dimers, polymers with glycerol and triglycerides.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-20-0019A</ENT>
                        <ENT>4</ENT>
                        <ENT>09/24/2021</ENT>
                        <ENT>CBI</ENT>
                        <ENT>(G) Component in candles</ENT>
                        <ENT>(G) Fatty acid dimers, polymers with glycerol and triglycerides.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-20-0020A</ENT>
                        <ENT>4</ENT>
                        <ENT>09/24/2021</ENT>
                        <ENT>CBI</ENT>
                        <ENT>(G) Component in candles</ENT>
                        <ENT>(G) Fatty acid dimers, polymers with glycerol and triglycerides.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-20-0021A</ENT>
                        <ENT>4</ENT>
                        <ENT>09/24/2021</ENT>
                        <ENT>CBI</ENT>
                        <ENT>(G) Component in candles</ENT>
                        <ENT>(G) Fatty acid dimers, polymers with glycerol and fatty acids.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-20-0105A</ENT>
                        <ENT>5</ENT>
                        <ENT>09/02/2021</ENT>
                        <ENT>Sound Agriculture Company</ENT>
                        <ENT>(S) To promote microbial activity in the soil (for use on commercial farming operations)</ENT>
                        <ENT>(S) 4H-Pyran-4-one, 3-[(2,5-dihydro-4-methyl-5-oxo-2-furanyl)oxy]-2-methyl-.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-21-0016A</ENT>
                        <ENT>2</ENT>
                        <ENT>09/27/2021</ENT>
                        <ENT>CBI</ENT>
                        <ENT>(G) Paint additive, Additive in coating formulations, Component in cleaning agents</ENT>
                        <ENT>(G) Alkanoic acid, dialkyl ester.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-21-0106A</ENT>
                        <ENT>3</ENT>
                        <ENT>09/02/2021</ENT>
                        <ENT>Eastman Chemical Company, Inc</ENT>
                        <ENT>(S) Chemical additive for production of tire and non-tire rubber products</ENT>
                        <ENT>(G) Distillates (petroleum), polymers with branched alkene.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-21-0107A</ENT>
                        <ENT>3</ENT>
                        <ENT>09/02/2021</ENT>
                        <ENT>Eastman Chemical Company, Inc</ENT>
                        <ENT>(S) Chemical additive for production of tire and non-tire rubber products</ENT>
                        <ENT>(G) Distillates (petroleum), polymers with branched alkene, hydrogenated.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-21-0172</ENT>
                        <ENT>4</ENT>
                        <ENT>08/31/2021</ENT>
                        <ENT>Silco, Inc</ENT>
                        <ENT>(S) Moisture reactive polymer for use in sealants and coatings</ENT>
                        <ENT>(G) Siloxanes and Silicones, di-Me, trimethoxysilyl group terminated.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-21-0172A</ENT>
                        <ENT>5</ENT>
                        <ENT>09/30/2021</ENT>
                        <ENT>Silco, Inc</ENT>
                        <ENT>(S) Moisture reactive polymer for use in sealants and coatings</ENT>
                        <ENT>(G) Siloxanes and Silicones, di-Me, trimethoxysilyl group terminated.</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="58660"/>
                        <ENT I="01">P-21-0178A</ENT>
                        <ENT>3</ENT>
                        <ENT>09/10/2021</ENT>
                        <ENT>CBI</ENT>
                        <ENT>(G) Coating additive</ENT>
                        <ENT>(G) Bisphenol A, polymer with aminoalkylalkyl-aminoalkylalkyl-poly[(oxy-alkyl-alkanepolyol)], haloalkyl-epoxide, epoxy-epoxyalkoxy-poly[(oxy-alkyl-alkanepolyol)], sulfur-based salt.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-21-0179A</ENT>
                        <ENT>3</ENT>
                        <ENT>09/10/2021</ENT>
                        <ENT>CBI</ENT>
                        <ENT>(G) Coating additive</ENT>
                        <ENT>(G) Substituted-alkanoic acid, compd. with aminoalkylalkyl-aminoalkylalkyl-poly[(oxy-alkyl-alkanepolyol)] polymer with haloalkyl-epoxide, bisphenol A,epoxy-epoxyalkoxy-poly[(oxy-alkyl-alkanepolyol)].</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-21-0181A</ENT>
                        <ENT>3</ENT>
                        <ENT>09/02/2021</ENT>
                        <ENT>CBI</ENT>
                        <ENT>(G) Color developer</ENT>
                        <ENT>(G) 1,3-Benzenedicarboxamide, N1,N3-bis(carbomonocyclic)-5-[[(carbomonocyclic)amino]sulfonyl]-.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-21-0190A</ENT>
                        <ENT>2</ENT>
                        <ENT>09/17/2021</ENT>
                        <ENT>Santolubes Manufacturing LLC</ENT>
                        <ENT>(S) This product will be used in gear oils &amp; greases, wind turbines, HX-1 (incidental food contact) lubricants and EV (Electric Vehicle) motors</ENT>
                        <ENT>(S) Poly(oxy-1,2-ethanediyl)-alpha-(1-oxohexyl)-omega-[(1-oxohexyl)oxy]-.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-21-0191A</ENT>
                        <ENT>2</ENT>
                        <ENT>09/17/2021</ENT>
                        <ENT>Santolubes Manufacturing LLC</ENT>
                        <ENT>(S) This product will be used in gear oils &amp; greases, wind turbines, HX-1 (incidental food contact) lubricants and EV (Electric Vehicle) motors</ENT>
                        <ENT>(S) Fatty acids, C18-unsatd., dimers, hydrogenated, polymers with polyethylene glycol, dihexanoates.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-21-0192A</ENT>
                        <ENT>2</ENT>
                        <ENT>09/17/2021</ENT>
                        <ENT>Santolubes Manufacturing LLC</ENT>
                        <ENT>(S) This product will be used in gear oils &amp; greases, wind turbines, HX-1 (incidental food contact) lubricants and EV (Electric Vehicle) motors</ENT>
                        <ENT>(S) Fatty acids, C18-unsatd., dimers, hydrogenated, polymers with polyethylene glycol, diesters with C8-10 fatty acids.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-21-0193A</ENT>
                        <ENT>3</ENT>
                        <ENT>09/17/2021</ENT>
                        <ENT>Santolubes Manufacturing LLC</ENT>
                        <ENT>(S) This product will be used in gear oils &amp; greases, wind turbines, HX-1 (incidental food contact) lubricants and EV (Electric Vehicle) motors</ENT>
                        <ENT>(S) Fatty acids, C8-10, diesters with polyethylene glycol.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-21-0199A</ENT>
                        <ENT>4</ENT>
                        <ENT>09/22/2021</ENT>
                        <ENT>CBI</ENT>
                        <ENT>(G) Processing aid</ENT>
                        <ENT>(G) 1,6-Disubstituted hexane.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-21-0201</ENT>
                        <ENT>5</ENT>
                        <ENT>08/30/2021</ENT>
                        <ENT>The Lewis Chemical Company</ENT>
                        <ENT>(S) The intention is for this product to be used as an offset to N,N,N′,N′,N″-Pentamethyl-N-tallow alkyl1,3- propanediammonium chloride (CAS#68607-29-4) in a cationic latex asphalt emulsion formulation</ENT>
                        <ENT>(S) 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3-tetradecyl-, chloride (1:2); 1,3-Propanediaminium, N-hexadecyl-2-hydroxy-N,N,N′,N′,N′-pentamethyl-, dichloride (2CI); 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3-octadecyl-, chloride (1:2); 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3-9-octadecen-1-yl, chloride (1:2).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-21-0206A</ENT>
                        <ENT>2</ENT>
                        <ENT>09/10/2021</ENT>
                        <ENT>HollyFrontier Corporation</ENT>
                        <ENT>(G) Component of gasoline</ENT>
                        <ENT>(G) Alkanes, branched and linear.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-21-0211</ENT>
                        <ENT>3</ENT>
                        <ENT>09/01/2021</ENT>
                        <ENT>CBI</ENT>
                        <ENT>(G) process aid</ENT>
                        <ENT>(G) Polycyclic Dioxolane.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-21-0212</ENT>
                        <ENT>2</ENT>
                        <ENT>09/06/2021</ENT>
                        <ENT>Orient Corporation of America</ENT>
                        <ENT>(S) Luminescent material for security ink</ENT>
                        <ENT>(G) Europium, tris[polyfluoro-1-(2-carbopolycyclic)-1,3-butanedionato-.kappa.O1,.kappa.O3]-.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-21-0214</ENT>
                        <ENT>1</ENT>
                        <ENT>08/31/2021</ENT>
                        <ENT>ICM Products Inc</ENT>
                        <ENT>(G) Textile finishing agent</ENT>
                        <ENT>(G) Poly(oxy-1,2-ethanediyl), alpha,alpha′,alpha″-(trialkylamino)tris[omega-hydroxy-, alkyl (ester).</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="58661"/>
                        <ENT I="01">P-21-0215</ENT>
                        <ENT>1</ENT>
                        <ENT>09/10/2021</ENT>
                        <ENT>Coventya, Inc</ENT>
                        <ENT>(S) The PMN substance is used in a primarily aqueous alkaline electroplating solution that produces a nominal zinc (Zn) nickel (Ni) alloy deposit on iron bearing substrates. The PMN substance is a secondary brightening additive that is used in instances where the inherent specularity of the plating deposit is unsatisfactory</ENT>
                        <ENT>(S) Pyridinium, 3-carboxy-1-methyl-, inner salt.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-21-0216</ENT>
                        <ENT>1</ENT>
                        <ENT>09/17/2021</ENT>
                        <ENT>CBI</ENT>
                        <ENT>(G) Additive in electrode materials, Additive in plastics</ENT>
                        <ENT>(G) Multi-walled carbon nanotubes.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-21-0217</ENT>
                        <ENT>1</ENT>
                        <ENT>09/17/2021</ENT>
                        <ENT>CBI</ENT>
                        <ENT>(G) Additive in electrode materials, Component in electrodes, thermoplastics</ENT>
                        <ENT>(G) Multi-walled carbon nanotubes.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SN-21-0003A</ENT>
                        <ENT>2</ENT>
                        <ENT>09/13/2021</ENT>
                        <ENT>Norquay Technology Inc</ENT>
                        <ENT>(G) Intermediate</ENT>
                        <ENT>(S) 1,1′-Biphenyl, 4,4′-dibromo-.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SN-21-0008A</ENT>
                        <ENT>3</ENT>
                        <ENT>09/30/2021</ENT>
                        <ENT>CBI</ENT>
                        <ENT>(G) Test media, Specialty fluid, Clean agent system, (S) Heat transfer system, Foam expansion agent</ENT>
                        <ENT>(S) 2-Butene, 1,1,1,4,4,4-hexafluoro-, (2Z)-.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SN-21-0009A</ENT>
                        <ENT>3</ENT>
                        <ENT>09/30/2021</ENT>
                        <ENT>CBI</ENT>
                        <ENT>(G) Not Applicable; Chemical Withdrawn</ENT>
                        <ENT>(S) 2-Butene, 1,1,1,4,4,4-hexafluoro-, (2E)-.</ENT>
                    </ROW>
                    <TNOTE>* The term ‘Approved’ indicates that a submission has passed a quick initial screen ensuring all required information and documents have been provided with the submission prior to the start of the 90 day review period, and in no way reflects the final status of a complete submission review.</TNOTE>
                </GPOTABLE>
                <P>
                    In Table II of this unit, EPA provides the following information (to the extent that such information is not claimed as CBI) on the NOCs that have passed an initial screening by EPA during this period: The EPA case number assigned to the NOC including whether the submission was an initial or amended submission, the date the NOC was received by EPA, the date of commencement provided by the submitter in the NOC, a notation of the type of amendment (
                    <E T="03">e.g.,</E>
                     amendment to generic name, specific name, technical contact information, etc.) and chemical substance identity.
                </P>
                <GPOTABLE COLS="5" OPTS="L2,nj,i1" CDEF="s50,14,14,12C,r100">
                    <TTITLE>Table II—NOCs Approved * From 09/01/2021 to 09/30/2021</TTITLE>
                    <BOXHD>
                        <CHED H="1">Case No.</CHED>
                        <CHED H="1">Received date</CHED>
                        <CHED H="1">Commencement date</CHED>
                        <CHED H="1">
                            If amendment,
                            <LI>type of</LI>
                            <LI>amendment</LI>
                        </CHED>
                        <CHED H="1">Chemical substance</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">P-18-0012</ENT>
                        <ENT>09/15/2021</ENT>
                        <ENT>08/31/2021</ENT>
                        <ENT>N</ENT>
                        <ENT>(G) Polyester polyol.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-18-0126</ENT>
                        <ENT>09/21/2021</ENT>
                        <ENT>09/13/2021</ENT>
                        <ENT>N</ENT>
                        <ENT>(S) Calcium manganese titanium oxide.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-18-0154</ENT>
                        <ENT>09/02/2021</ENT>
                        <ENT>08/27/2021</ENT>
                        <ENT>N</ENT>
                        <ENT>(G) Isocyanic acid, polyalkylenepolycycloalkylene ester, 2-alkoxy alkanol and 1-alkoxy alkanol and alkylene diol blocked.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-19-0019</ENT>
                        <ENT>09/10/2021</ENT>
                        <ENT>08/21/2021</ENT>
                        <ENT>N</ENT>
                        <ENT>(G) Haloalkane.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-19-0020</ENT>
                        <ENT>09/01/2021</ENT>
                        <ENT>08/27/2021</ENT>
                        <ENT>N</ENT>
                        <ENT>(G) Alkyl salicylate, metal salts.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-21-0087</ENT>
                        <ENT>09/17/2021</ENT>
                        <ENT>09/12/2021</ENT>
                        <ENT>N</ENT>
                        <ENT>(G) Syrups, hydrolyzed starch, dehydrated, polymers with methacrylic acid and alkenenylbenzene.</ENT>
                    </ROW>
                    <TNOTE>* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required information and documents have been provided with the submission</TNOTE>
                </GPOTABLE>
                <P>In Table III of this unit, EPA provides the following information (to the extent such information is not subject to a CBI claim) on the test information that has been received during this time period: The EPA case number assigned to the test information; the date the test information was received by EPA, the type of test information submitted, and chemical substance identity.</P>
                <GPOTABLE COLS="4" OPTS="L2,nj,i1" CDEF="s50,r50,r50,r50">
                    <TTITLE>Table III—Test Information Received From 09/01/2021 to 09/30/2021</TTITLE>
                    <BOXHD>
                        <CHED H="1">Case No.</CHED>
                        <CHED H="1">Received date</CHED>
                        <CHED H="1">Type of test information</CHED>
                        <CHED H="1">Chemical substance</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">P-14-0712</ENT>
                        <ENT>09/22/2021</ENT>
                        <ENT>Quarterly PCDD/F Test of PMN Substance using EPA Test Method 8290A</ENT>
                        <ENT>(G) Plastics, wastes, pyrolyzed, bulk pyrolysate.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-16-0543</ENT>
                        <ENT>08/30/2021</ENT>
                        <ENT>Exposure Monitoring Report</ENT>
                        <ENT>(G) Halogenophosphoric acid metal salt.</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="58662"/>
                        <ENT I="01">P-16-0543</ENT>
                        <ENT>09/23/2021</ENT>
                        <ENT>Exposure Monitoring Report</ENT>
                        <ENT>(G) Halogenophosphoric acid metal salt.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">P-19-0049</ENT>
                        <ENT>09/17/2021</ENT>
                        <ENT>Fish Acute Toxicity Test with Humic Acid, Daphnia Acute Toxicity Test, and Green Algae 96-Hour Toxicity Test</ENT>
                        <ENT>(G) Fatty acids, polymers with substituted carbomonocycles, dialkanolamine, alkyl substituted alkanediamine and halo-substituted heteromonocycle, formates (salts).</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    If you are interested in information that is not included in these tables, you may contact EPA's technical information contact or general information contact as described under 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     to access additional non-CBI information that may be available.
                </P>
                <EXTRACT>
                    <FP>
                        (Authority: 15 U.S.C. 2601 
                        <E T="03">et seq.</E>
                        )
                    </FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: October 18, 2021.</DATED>
                    <NAME>Pamela Myrick,</NAME>
                    <TITLE>Director, Project Management and Operations Division, Office of Pollution Prevention and Toxics.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23085 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">FEDERAL LABOR RELATIONS AUTHORITY</AGENCY>
                <SUBJECT>Senior Executive Service Performance Review Board</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Labor Relations Authority.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Federal Labor Relations Authority (FLRA) publishes the names of the persons selected to serve on its SES Performance Review Board (PRB). This notice supersedes all previous notices of the PRB membership.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>October 22, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Written comments about this notice can be mailed to the Case Intake and Publication Office, Federal Labor Relations Authority, 1400 K Street NW, Washington, DC 20424.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Michael Jeffries, Executive Director, Federal Labor Relations Authority, 1400 K St. NW, Washington, DC 20424, (202) 218-7982, 
                        <E T="03">mjeffries@flra.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 4314(c) of Title 5, U.S.C. requires each agency to establish, in accordance with regulations prescribed by the Office of Personnel Management, one or more PRBs. The PRB shall review and evaluate the initial appraisal of a senior executive's performance by the supervisor, along with any response by the senior executive, and make recommendations to the final rating authority relative to the performance of the senior executive.</P>
                <P>The persons named below have been selected to serve on the FLRA's PRB.</P>
                <P>PRB Chairman: </P>
                <EXTRACT>
                    <FP SOURCE="FP-1">Michael Jeffries, Executive Director, FLRA, and PRB Chairman</FP>
                </EXTRACT>
                <P>PRB Members: </P>
                <EXTRACT>
                    <FP SOURCE="FP-1">Kimberly Moseley, Executive Director, Federal Service Impasses Panel</FP>
                    <FP SOURCE="FP-1">Charlotte Dye, Deputy General Counsel, FLRA</FP>
                    <FP SOURCE="FP-1">Timothy Curry, Deputy Associate Director, Accountability and Workforce Relations, Employee Services, Office of Personnel Management</FP>
                    <FP SOURCE="FP-1">Paula Chandler, Director, Human Resources Division, FLRA (Ex Officio). </FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>Rebecca J. Osborne,</NAME>
                    <TITLE>Federal Register Liaison, FLRA.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23066 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7627-01-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 November 8, 2021.</P>
                <HD SOURCE="HD1">
                    <E T="03">A. Federal Reserve Bank of Dallas</E>
                      
                    <E T="01">(Karen Smith, Director, Applications) 2200 North Pearl Street, Dallas, Texas 75201-2272:</E>
                </HD>
                <P>
                    1. 
                    <E T="03">The Katherine Orsak Irrevocable Asset Trust, Katherine Orsak, individually, and as trustee, and Stephen Paul Orsak, all of Dallas, Texas; the John Stephen Cecil Irrevocable Asset Trust, John Stephen Cecil, individually, and as trustee, and Meredith Julie Cecil, all of San Angelo, Texas; Stephanie Sawyer Cecil, and the Carl Cecil Irrevocable Asset Trust, Carl Thomas Cecil, individually, and as trustee, all of Paris, Texas; the Randle R. Cecil Trust A, Paris, Texas, and the Conger Family Partnership, and Jean Conger, individually, as trustee of the trust, and as general partner of the family partnership, both of Houston Texas;</E>
                     as a group acting in concert, to retain voting shares of Paris Bancshares, Inc., and thereby indirectly retain voting shares of The Liberty National Bank, both of Paris, Texas.
                </P>
                <SIG>
                    <DATED>Board of Governors of the Federal Reserve System, October 19, 2021.</DATED>
                    <NAME>Michele Taylor Fennell,</NAME>
                    <TITLE>Deputy Associate Secretary of the Board.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23100 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="58663"/>
                <AGENCY TYPE="N">GENERAL SERVICES ADMINISTRATION</AGENCY>
                <DEPDOC>[Notice MG-2021-03; Docket No. 2021-0002; Sequence No. 25]</DEPDOC>
                <SUBJECT>Office of Federal High-Performance Green Buildings; Green Building Advisory Committee; Notification of Upcoming Web-Based Meetings</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Government-wide Policy, General Services Administration (GSA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of public meetings.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        Notice of these web-based public meetings/conference calls is being provided according to the requirements of the Federal Advisory Committee Act. This notice provides the schedule for one full Committee meeting of the Green Building Advisory Committee (Committee), which is open to the public. Interested individuals must register to attend and provide public comment as instructed below under 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                        .
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The Green Building Advisory Committee will hold a web-based meeting on Tuesday, November 16, 2021, from 11:00 a.m. to 4:00 p.m., Eastern Time (ET).</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Michael Bloom, Designated Federal Officer, Office of Federal High-Performance Green Buildings, Office of Government-wide Policy, General Services Administration, at 
                        <E T="03">michael.bloom@gsa.gov</E>
                         or 312-805-6799. Additional information about the Committee, including meeting materials and agendas, will be available on-line at 
                        <E T="03">http://www.gsa.gov/gbac.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    The Administrator of GSA established the Committee on June 20, 2011 (
                    <E T="04">Federal Register</E>
                    /Vol. 76, No. 118) pursuant to Section 494 of the Energy Independence and Security Act of 2007 (EISA, 42 U.S.C. 17123). Under this authority, the Committee provides independent policy advice and recommendations to GSA to advance federal building innovations in planning, design, and operations to reduce costs, enable agency missions, enhance human health and performance, and minimize environmental impacts.
                </P>
                <HD SOURCE="HD1">Procedures for Attendance and Public Comment</HD>
                <P>
                    Contact Michael Bloom, at 
                    <E T="03">michael.bloom@gsa.gov,</E>
                     to register to attend this public web-based meetings. To register, submit your full name, organization, email address, phone number. Requests to attend this web-based meeting must be received by 5:00 p.m. ET, on Wednesday, November 10, 2021. Meeting call-in information will be provided to interested parties who register by the deadline. (GSA will be unable to provide technical assistance to any listener experiencing technical difficulties. Testing access to the web-based meeting site before the meetings is recommended.)
                </P>
                <P>Contact Mr. Bloom to register to provide public comment during the November 16th, 2021 meeting public comment period. Registered speakers/organizations will be allowed a maximum of five minutes each and will need to provide written copies of their presentations. Requests to provide public comment at the Committee meeting must be received by 5:00 p.m., ET, on Monday, November 8, 2021.</P>
                <HD SOURCE="HD1">November 16, 2021 Meeting Agenda</HD>
                <FP SOURCE="FP-1">• Updates and introductions</FP>
                <FP SOURCE="FP-1">• Federal Building Decarbonization Task Group: Findings &amp; Recommendations</FP>
                <FP SOURCE="FP-1">• Environmental Justice and Equity Task Group: Findings &amp; Recommendations</FP>
                <FP SOURCE="FP-1">• Energy Storage Task Group: Final Vote to Accept Advice Letter</FP>
                <FP SOURCE="FP-1">• New committee directions &amp; topics to explore</FP>
                <FP SOURCE="FP-1">• Public comment</FP>
                <FP SOURCE="FP-1">• Next steps and closing comments</FP>
                <SIG>
                    <NAME>Kevin Kampschroer,</NAME>
                    <TITLE>Federal Director, Office of Federal High-Performance Green Buildings, Office of Government-wide Policy, General Services Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23068 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6820-14-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Centers for Disease Control and Prevention</SUBAGY>
                <DEPDOC>[Docket No. CDC-2021-0112]</DEPDOC>
                <SUBJECT>Advisory Committee on Immunization Practices (ACIP)</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 the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web; for more information on ACIP please visit the ACIP website: 
                        <E T="03">http://www.cdc.gov/vaccines/acip/index.html.</E>
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The meeting will be held on November 2-3, 2021, from 10:00 a.m. to 5:00 p.m., EDT (times subject to change). The public may submit written comments from October 22, 2021 through November 3, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by Docket No. CDC-2021-0112 by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                          
                        <E T="03">https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H24-8, Atlanta, Georgia 30329-4027, Attn: ACIP Meeting.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the Agency name and Docket Number. All relevant comments received in conformance with the 
                        <E T="03">https://www.regulations.gov</E>
                         suitability policy will be posted without change to 
                        <E T="03">https://www.regulations.gov,</E>
                         including any personal information provided. For access to the docket to read background documents or comments received, go to 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                    <P>Written public comments submitted up to 72 hours prior to the ACIP meeting will be provided to ACIP members before the meeting.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Stephanie Thomas, ACIP Committee Management Specialist, Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases, 1600 Clifton Road NE, MS-H24-8, Atlanta, Georgia 30329-4027; Telephone: (404) 639-8367; Email: 
                        <E T="03">ACIP@cdc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    In accordance with 41 CFR 102-3.150(b), less than 15 calendar days' notice is being given for this meeting due to the exceptional circumstances of the COVID-19 pandemic and rapidly evolving COVID-19 vaccine development and regulatory processes. The Secretary of Health and Human Services has determined that COVID-19 is a Public Health Emergency. A notice of this ACIP meeting has also been posted on CDC's ACIP website at: 
                    <E T="03">http://www.cdc.gov/vaccines/acip/index.html.</E>
                     In addition, CDC has sent notice of this ACIP meeting by email to those who subscribe to receive email updates about ACIP.
                </P>
                <P>
                    <E T="03">Purpose:</E>
                     The committee is charged with advising the Director, CDC, on the 
                    <PRTPAGE P="58664"/>
                    use of immunizing agents. In addition, under 42 U.S.C. 1396s, the committee is mandated to establish and periodically review and, as appropriate, revise the list of vaccines for administration to vaccine-eligible children through the Vaccines for Children program, along with schedules regarding dosing interval, dosage, and contraindications to administration of vaccines. Further, under provisions of the Affordable Care Act, section 2713 of the Public Health Service Act, immunization recommendations of the ACIP that have been approved by the CDC Director and appear on CDC immunization schedules must be covered by applicable health plans.
                </P>
                <P>
                    <E T="03">Matters To Be Considered:</E>
                     The agenda will include discussions on adult immunization schedule, child/adolescent immunization schedule, Ebola vaccine, hepatitis vaccines, Orthopoxviruses vaccine and COVID vaccines. Recommendation votes on adult immunization schedule, child/adolescent immunization schedule, hepatitis vaccine, Orthopoxviruses vaccine, Ebola vaccine and COVID vaccines are scheduled. No Vaccines for Children votes are scheduled. Agenda items are subject to change as priorities dictate. For more information on the meeting agenda visit 
                    <E T="03">https://www.cdc.gov/vaccines/acip/meetings/meetings-info.html.</E>
                </P>
                <HD SOURCE="HD1">Public Participation</HD>
                <P>
                    Interested persons or organizations are invited to participate by submitting written views, recommendations, and data. Please note that comments received, including attachments and other supporting materials, are part of the public record and are subject to public disclosure. Comments will be posted on 
                    <E T="03">https://www.regulations.gov.</E>
                     Therefore, 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">Written Public Comment:</E>
                     The docket will be opened to receive written comments on October 22, 2021. Written comments must be received on or before November 3, 2021.
                </P>
                <P>
                    <E T="03">Oral Public Comment:</E>
                     This meeting will include time for members of the public to make an oral comment. Oral public comment will occur before any scheduled votes including all votes relevant to the ACIP's Affordable Care Act and Vaccines for Children Program roles. Priority will be given to individuals who submit a request to make an oral public comment before the meeting according to the procedures below.
                </P>
                <P>
                    <E T="03">Procedure for Oral Public Comment:</E>
                     All persons interested in making an oral public comment at the November 2-3, 2021 ACIP meeting must submit a request at 
                    <E T="03">http://www.cdc.gov/vaccines/acip/meetings/</E>
                     no later than 11:59 p.m., EDT, October 31, 2021, according to the instructions provided.
                </P>
                <P>If the number of persons requesting to speak is greater than can be reasonably accommodated during the scheduled time, CDC will conduct a lottery to determine the speakers for the scheduled public comment session. CDC staff will notify individuals regarding their request to speak by email by November 1, 2021. To accommodate the significant interest in participation in the oral public comment session of ACIP meetings, each speaker will be limited to 3 minutes, and each speaker may only speak once per meeting.</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. 2021-23222 Filed 10-20-21; 4:15 pm]</FRDOC>
            <BILCOD>BILLING CODE 4163-18-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Centers for Medicare &amp; Medicaid Services</SUBAGY>
                <DEPDOC>[Document Identifiers: CMS-2567, CMS-10790 and CMS-10463]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities: Proposed Collection; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Centers for Medicare &amp; Medicaid Services, Health and Human Services (HHS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Centers for Medicare &amp; Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the 
                        <E T="04">Federal Register</E>
                         concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received by December 21, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:</P>
                    <P>
                        1. 
                        <E T="03">Electronically.</E>
                         You may send your comments electronically to 
                        <E T="03">http://www.regulations.gov.</E>
                         Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.
                    </P>
                    <P>
                        2. 
                        <E T="03">By regular mail.</E>
                         You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number: __, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
                        <PRTPAGE P="58665"/>
                    </P>
                    <P>To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:</P>
                    <P>
                        1. Access CMS' website address at website address at 
                        <E T="03">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>William N. Parham at (410) 786-4669.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Contents</HD>
                <P>
                    This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see 
                    <E T="02">ADDRESSES</E>
                    ).
                </P>
                <FP SOURCE="FP-1">CMS-2567 Statement of Deficiency and Plan of Correction</FP>
                <FP SOURCE="FP-1">CMS-10790 Medicare-Funded GME Residency Positions in accordance with Section 126 of the Consolidated Appropriations Act, 2020 (Pub. L. 116-93)</FP>
                <FP SOURCE="FP-1">CMS-10463 Cooperative Agreement to Support Navigators in Federally-facilitated Exchanges</FP>
                <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. The term “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 publish a 60-day notice in the 
                    <E T="04">Federal Register</E>
                     concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.
                </P>
                <HD SOURCE="HD1">Information Collection</HD>
                <P>
                    1. 
                    <E T="03">Type of Information Collection Request:</E>
                     Revision of a currently approved collection; 
                    <E T="03">Title of Information Collection:</E>
                     Statement of Deficiency and Plan of Correction 
                    <E T="03">Use:</E>
                     The form CMS-2567 is the means by which State and CMS surveyors document findings of compliance or noncompliance (deficiencies) resulting from inspection of Medicare, Medicaid, and Clinical Laboratory Improvement Amendments (CLIA) laboratories. The form CMS-2567 is the legal, documentary basis for CMS' certification of a facility's compliance or noncompliance with the Medicare/Medicaid Conditions of Participation or Coverage, and the requirements for Nursing Home participation and CLIA certification.
                </P>
                <P>
                    In December, 2020, Congress passed the Consolidated Appropriations Act, 2021 (CAA, 2021). Section 407 of CAA, 2021, amended Part A of Title XVIII of the Social Security Act (the Act) at section 1822 establishing hospice program survey and enforcement requirements. This amendment, in part, now requires the Accrediting Organizations (AOs) that accredit hospice programs to include the form CMS-2567 to document the findings of their hospice program surveys beginning on October 1, 2021. As of June 2021, there are three AOs with CMS-approved hospice accreditation programs. The AOs survey approximately half of the over 5,000 Medicare-certified hospice programs, while the SAs survey the remaining half. 
                    <E T="03">Form Numbers:</E>
                     CMS-2567 (OMB control number: 0938-0391); 
                    <E T="03">Frequency:</E>
                     Yearly and Occasionally; 
                    <E T="03">Affected Public:</E>
                     Private Sector (Business or for-profits and Not-for-profit institutions); 
                    <E T="03">Number of Respondents:</E>
                     65,948; 
                    <E T="03">Total Annual Responses:</E>
                     65,948; 
                    <E T="03">Total Annual Hours:</E>
                     1,187,064. (For policy questions regarding this collection contact Caroline Gallaher at 410-786-8705.)
                </P>
                <P>
                    2. 
                    <E T="03">Type of Information Collection Request:</E>
                     New collection (Request for a new OMB Control Number); 
                    <E T="03">Title of Information Collection:</E>
                     Medicare-Funded GME Residency Positions in accordance with Section 126 of the Consolidated Appropriations Act, 2020 (Pub. L. 116-93); 
                    <E T="03">Use:</E>
                     The requirements in this rule were announced in CMS-1752-P (FY22 IPPS); however, the PRA package has been under development until now. The plan, approved by OMB and CM, is to have the 60-day publish and then have CMS-1752-F2 serve as the 30-day notice, with the goal of approval in early January 2022.
                </P>
                <P>Section 126 of the Consolidated Appropriations Act (CAA), 2021 (Pub. L. 116-93), enacted December 20, 2020, included a key provision affecting Medicare payments for Graduate Medical Education (GME). Section 126(a) of the CAA amended section 1886(h) of the Act by adding a new section 1886(h)(9) requiring the distribution of additional residency positions (slots) to qualifying hospitals. Section 1886(h)(9)(A) makes an additional 1,000 Medicare funded residency slots available to be phased in beginning in FY 2023 until the aggregate number of 1,000 full-time equivalent residency positions are distributed.</P>
                <P>
                    This approval request is for CMS to receive electronic applications for Medicare-Funded GME Residency Positions submitted in accordance with Section 126 of the Consolidated Appropriations Act, 2021. The electronic applications will be submitted by the applicants in CMS' new Medicare Electronic Application Request Information System
                    <E T="51">TM</E>
                     (MEARIS
                    <E T="51">TM</E>
                    ). There is no existing, hard copy version of the application. The applications will provide CMS with the critical information necessary for CMS to process and score the applications in accordance with the policies finalized in the upcoming final rule to determine the disbursement of the slots and to announce the awardees by the January 31, 2023 required statutory deadline. 
                    <E T="03">Form Number:</E>
                     CMS-10790 (OMB control number: 0938-NEW); 
                    <E T="03">Frequency:</E>
                     Yearly; 
                    <E T="03">Affected Public:</E>
                     Private sector (Business or other for-profits and Not-for-profit institutions), State, Local, or Tribal Governments; 
                    <E T="03">Number of Respondents:</E>
                     1,325; 
                    <E T="03">Total Annual Responses:</E>
                     1,325; 
                    <E T="03">Total Annual Hours:</E>
                     10,600. (For policy questions regarding this collection contact Noel Manlove at 410-786-5161.)
                </P>
                <P>
                    3. 
                    <E T="03">Type of Information Collection Request:</E>
                     Revision of a currently approved collection; 
                    <E T="03">Title of Information Collection:</E>
                     Cooperative Agreement to Support Navigators in Federally-facilitated Exchanges; 
                    <E T="03">Use:</E>
                     Section 1311(i) of the PPACA requires Exchanges to establish a Navigator grant program under which it awards grants to eligible individuals and entities (as described in Section 1311(i)(2) of the PPACA and 45 CFR 155.210(a) and (c)) applying to serve consumers in States with a FFE. Navigators assist consumers by providing education about and facilitating selection of qualified health plans (QHPs) within the Exchanges, as well as other required duties. Entities and individuals cannot serve as federally certified Navigators and carry out the required duties without receiving federal cooperative agreement funding. On July 1, 2021, HHS published the Updating Payment Parameters, Section 1332 Waiver Implementing Regulations, and Improving Health Insurance Markets for 2022 and Beyond Proposed Rule proposed rule. The proposed regulations would amend federal regulations at 45 CFR 155.210(e)(9) to reinstitute the requirement that FFE Navigators provide consumers with information and assistance on access, affordability and certain post-enrollment topics, such 
                    <PRTPAGE P="58666"/>
                    as the eligibility appeals process, the Exchange-related components of the Premium Tax Credit (PTC) reconciliation process, and the basic concepts and rights of health coverage and how to use it.
                </P>
                <P>
                    Under the Terms and Conditions of the Navigator program cooperative agreements, awardees must provide progress reports on a weekly, monthly, quarterly and annual basis during the cooperative agreement period of performance, and a final report at the end of the period of performance. Awardees will submit their progress reports electronically to CMS staff for evaluation and analysis. The results of this evaluation will provide feedback on the effectiveness of the Navigator program, so that HHS and CMS leadership may evaluate the effectiveness of the program and address any areas that need revisions. CMS will also use the information collected from Navigator grant awardees to inform the public about the availability of application and enrollment assistance services from designated organizations. 
                    <E T="03">Form Number:</E>
                     CMS-10463 (OMB control number: 0938-1215); 
                    <E T="03">Frequency:</E>
                     Annually, Monthly, Quarterly, Weekly; 
                    <E T="03">Affected Public:</E>
                     Private sector; 
                    <E T="03">Number of Respondents:</E>
                     100; 
                    <E T="03">Total Annual Responses:</E>
                     5,200; 
                    <E T="03">Total Annual Hours:</E>
                     529,000. (For questions regarding this collection contact Gian Johnson at 301-492-4323.)
                </P>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>William N. Parham, III,</NAME>
                    <TITLE>Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23107 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4120-01-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-2012-N-0559]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Proposed Collection; Comment Request; Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Food and Drug Administration, HHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to this notice. This notice solicits comments on the collection of information contained in the Public Health Service (PHS) guideline entitled “PHS Guideline on Infectious Disease Issues in Xenotransplantation.”
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit either electronic or written comments on the collection of information by December 21, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 21, 2021. The 
                        <E T="03">https://www.regulations.gov</E>
                         electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 21, 2021. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
                    </P>
                </ADD>
                <HD SOURCE="HD2">Electronic Submissions</HD>
                <P>Submit electronic comments in the following way:</P>
                <P>
                    • 
                    <E T="03">Federal eRulemaking Portal:</E>
                      
                    <E T="03">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-2012-N-0559 for “PHS Guideline on Infectious Disease Issues in Xenotransplantation.” Received comments, those filed in a timely manner (see 
                    <E T="02">ADDRESSES</E>
                    ), 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 
                    <PRTPAGE P="58667"/>
                    Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Rachel Showalter, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
                        <E T="03">PRAStaff@fda.hhs.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Under the PRA (44 U.S.C. 3501-3521), 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 (44 U.S.C. 3506(c)(2)(A)) 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, FDA is publishing notice of the proposed collection of information set forth in this document.
                </P>
                <P>With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.</P>
                <HD SOURCE="HD1">PHS Guideline on Infectious Disease Issues in Xenotransplantation</HD>
                <HD SOURCE="HD2">OMB Control Number 0910-0456—Extension</HD>
                <P>
                    This information collection helps support implementation of the Department of Health and Human Services' “PHS Guideline on Infectious Disease Issues in Xenotransplantation.” FDA is authorized to collect this information under sections 351 and 361 of the PHS Act (42 U.S.C. 262 and 264) and provisions of the Federal Food, Drug, and Cosmetic Act that apply to drugs (21 U.S.C. 321 
                    <E T="03">et seq.</E>
                    ). The guideline, available from our website at 
                    <E T="03">https://www.fda.gov/media/73803/download</E>
                     was developed by the PHS to identify general principles for the prevention and control of infectious diseases associated with xenotransplantation that may pose a risk to public health. The PHS guideline recommends procedures to diminish the risk of transmission of infectious agents to the xenotransplantation product recipient and to the general public. The PHS guideline is intended to address public health issues raised by xenotransplantation, through identification of general principles of prevention and control of infectious diseases associated with xenotransplantation that may pose a hazard to the public health. The collection of information described in this guideline is intended to provide general guidance on the following topics: (1) The development of xenotransplantation clinical protocols; (2) the preparation of submissions to FDA; and (3) the conduct of xenotransplantation clinical trials. Also, the collection of information will help ensure that the sponsor maintains important information in a cross-referenced system that links the relevant records of the xenotransplantation product recipient, xenotransplantation product, source animal(s), animal procurement center, and significant nosocomial exposures. The PHS guideline also describes an occupational health service program for the protection of health care workers involved in xenotransplantation procedures, caring for xenotransplantation product recipients, and performing associated laboratory testing. The PHS guideline is intended to protect the public health and to help ensure the safety of using xenotransplantation products in humans by preventing the introduction, transmission, and spread of infectious diseases associated with xenotransplantation.
                </P>
                <P>The PHS guideline also recommends that certain specimens and records be maintained for 50 years beyond the date of the xenotransplantation. These include: (1) Records linking each xenotransplantation product recipient with relevant health records of the source animal, herd or colony, and the specific organ, tissue, or cell type included in or used in the manufacture of the product (3.2.7.1); (2) aliquots of serum samples from randomly selected animal and specific disease investigations (3.4.3.1); (3) source animal biological specimens designated for PHS use (3.7.1); animal health records (3.7.2), including necropsy results (3.6.4); and (4) recipients' biological specimens (4.1.2). The retention period is intended to assist health care practitioners and officials in surveillance and in tracking the source of an infection, disease, or illness that might emerge in the recipient, the source animal, or the animal herd or colony after a xenotransplantation.</P>
                <P>
                    The recommendation for maintaining records for 50 years is based on clinical experience with several human viruses that have presented problems in human to human transplantation and are therefore thought to share certain characteristics with viruses that may pose potential risks in xenotransplantation. These characteristics include long latency periods and the ability to establish persistent infections. Several also share the possibility of transmission among individuals through intimate contact with human body fluids. Human immunodeficiency virus (HIV) and Human T-lymphotropic virus are human retroviruses. Retroviruses contain ribonucleic acid that is reverse-transcribed into deoxyribonucleic acid (DNA) using an enzyme provided by the virus and the human cell machinery. That viral DNA can then be integrated into the human cellular DNA. Both viruses establish persistent infections and have long latency periods before the onset of disease, 10 years and 40 to 60 years, respectively. The human hepatitis viruses are not retroviruses, but several share with HIV the characteristic that they can be transmitted through body fluids, can establish persistent infections, and have long latency periods, 
                    <E T="03">e.g.,</E>
                     approximately 30 years for Hepatitis C.
                </P>
                <P>In addition, the PHS guideline recommends that a record system be developed that allows easy, accurate, and rapid linkage of information among the specimen archive, the recipient's medical records, and the records of the source animal for 50 years. The development of such a record system is a one-time burden. Such a system is intended to cross-reference and locate relevant records of recipients, products, source animals, animal procurement centers, and significant nosocomial exposures.</P>
                <P>
                    Respondents to this collection of information are the sponsors of clinical studies of investigational xenotransplantation products under investigational new drug applications (INDs) and xenotransplantation product procurement centers, referred to as source animal facilities. There are an estimated three respondents who are 
                    <PRTPAGE P="58668"/>
                    sponsors of INDs that include protocols for xenotransplantation in humans and five clinical centers doing xenotransplantation procedures. Other respondents for this collection of information are an estimated four source animal facilities which provide source xenotransplantation product material to sponsors for use in human xenotransplantation procedures. These four source animal facilities keep medical records of the herds/colonies as well as the medical records of the individual source animal(s). The burden estimates are based on FDA's records of xenotransplantation-related INDs and estimates of time required to complete the various reporting, recordkeeping, and third-party disclosure tasks described in the PHS guideline.
                </P>
                <P>FDA is requesting an extension of OMB approval for the following reporting, recordkeeping, and third-party disclosure recommendations in the PHS guideline:</P>
                <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s50,r150">
                    <TTITLE>Table 1—Reporting Recommendations</TTITLE>
                    <BOXHD>
                        <CHED H="1">PHS guideline section</CHED>
                        <CHED H="1">Description</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">3.2.7.2</ENT>
                        <ENT>Notify sponsor or FDA of new archive site when the source animal facility or sponsor ceases operations.</ENT>
                    </ROW>
                </GPOTABLE>
                <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s50,r150">
                    <TTITLE>Table 2—Recordkeeping Recommendations</TTITLE>
                    <BOXHD>
                        <CHED H="1">PHS guideline section</CHED>
                        <CHED H="1">Description</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">3.2.7</ENT>
                        <ENT>Establish records linking each xenotransplantation product recipient with relevant records.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">4.3</ENT>
                        <ENT>Sponsor to maintain cross-referenced system that links all relevant records (recipient, product, source animal, animal procurement center, and nosocomial exposures).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.4.2</ENT>
                        <ENT>Document results of monitoring program used to detect introduction of infectious agents which may not be apparent clinically.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.4.3.2</ENT>
                        <ENT>Document full necropsy investigations including evaluation for infectious etiologies.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.5.1</ENT>
                        <ENT>Justify shortening a source animal's quarantine period of 3 weeks prior to xenotransplantation product procurement.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.5.2</ENT>
                        <ENT>Document absence of infectious agent in xenotransplantation product if its presence elsewhere in source animal does not preclude using it.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.5.4</ENT>
                        <ENT>Add summary of individual source animal record to permanent medical record of the xenotransplantation product recipient.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.6.4</ENT>
                        <ENT>Document complete necropsy results on source animals (50-year record retention).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.7</ENT>
                        <ENT>Link xenotransplantation product recipients to individual source animal records and archived biologic specimens.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">4.2.3.2</ENT>
                        <ENT>Record baseline sera of xenotransplantation health care workers and specific nosocomial exposure.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">4.2.3.3 and 4.3.2</ENT>
                        <ENT>Keep a log of health care workers' significant nosocomial exposure(s).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">4.3.1</ENT>
                        <ENT>Document each xenotransplant procedure.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">5.2</ENT>
                        <ENT>Document location and nature of archived specimens in health care records of xenotransplantation product recipient and source animal.</ENT>
                    </ROW>
                </GPOTABLE>
                <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s50,r150">
                    <TTITLE>Table 3—Disclosure Recommendations</TTITLE>
                    <BOXHD>
                        <CHED H="1">PHS guideline section</CHED>
                        <CHED H="1">Description</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">3.2.7.2</ENT>
                        <ENT>Notify sponsor or FDA of new archive site when the source animal facility or sponsor ceases operations.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.4</ENT>
                        <ENT>Standard operating procedures (SOPs) of source animal facility should be available to review bodies.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.5.1</ENT>
                        <ENT>Include increased infectious risk in informed consent if source animal quarantine period of 3 weeks is shortened.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.5.4</ENT>
                        <ENT>Sponsor to make linked records described in section 3.2.7 available for review.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.5.5</ENT>
                        <ENT>Source animal facility to notify clinical center when infectious agent is identified in source animal or herd after xenotransplantation product procurement.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>FDA estimates the burden for this collection of information as follows:</P>
                <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s50,12,12,12,r50,12">
                    <TTITLE>
                        Table 4—Estimated Annual Reporting Burden 
                        <SU>1</SU>
                    </TTITLE>
                    <BOXHD>
                        <CHED H="1">PHS guideline section</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">
                            Total annual
                            <LI>responses</LI>
                        </CHED>
                        <CHED H="1">Average burden per response</CHED>
                        <CHED H="1">Total hours</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">
                            3.2.7.2 
                            <SU>2</SU>
                        </ENT>
                        <ENT>1</ENT>
                        <ENT>1</ENT>
                        <ENT>1</ENT>
                        <ENT>0.50 (30 minutes)</ENT>
                        <ENT>0.5</ENT>
                    </ROW>
                    <TNOTE>
                        <SU>1</SU>
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
                    </TNOTE>
                    <TNOTE>
                        <SU>2</SU>
                         FDA is using one animal facility or sponsor for estimation purposes.
                    </TNOTE>
                </GPOTABLE>
                <PRTPAGE P="58669"/>
                <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s50,12,12,12,r50,12">
                    <TTITLE>
                        Table 5—Estimated Annual Recordkeeping Burden 
                        <SU>1</SU>
                    </TTITLE>
                    <BOXHD>
                        <CHED H="1">PHS guideline section</CHED>
                        <CHED H="1">Number of recordkeepers</CHED>
                        <CHED H="1">Number of records per recordkeeper</CHED>
                        <CHED H="1">Total annual records</CHED>
                        <CHED H="1">Average burden per recordkeeping</CHED>
                        <CHED H="1">Total hours</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">
                            3.2.7 
                            <SU>2</SU>
                        </ENT>
                        <ENT>1</ENT>
                        <ENT>1</ENT>
                        <ENT>1</ENT>
                        <ENT>16</ENT>
                        <ENT>16</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            4.3 
                            <SU>3</SU>
                        </ENT>
                        <ENT>3</ENT>
                        <ENT>1</ENT>
                        <ENT>3</ENT>
                        <ENT>0.75 (45 minutes)</ENT>
                        <ENT>2.25</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            3.4.2 
                            <SU>4</SU>
                        </ENT>
                        <ENT>3</ENT>
                        <ENT>10.67</ENT>
                        <ENT>32</ENT>
                        <ENT>0.25 (15 minutes)</ENT>
                        <ENT>8</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            3.4.3.2 
                            <SU>5</SU>
                        </ENT>
                        <ENT>3</ENT>
                        <ENT>2.67</ENT>
                        <ENT>8</ENT>
                        <ENT>0.25 (15 minutes)</ENT>
                        <ENT>2</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            3.5.1 
                            <SU>6</SU>
                        </ENT>
                        <ENT>3</ENT>
                        <ENT>0.33</ENT>
                        <ENT>1</ENT>
                        <ENT>0.50 (30 minutes)</ENT>
                        <ENT>0.50</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            3.5.2 
                            <SU>6</SU>
                        </ENT>
                        <ENT>3</ENT>
                        <ENT>0.33</ENT>
                        <ENT>1</ENT>
                        <ENT>0.25 (15 minutes)</ENT>
                        <ENT>0.25</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.5.4</ENT>
                        <ENT>3</ENT>
                        <ENT>1</ENT>
                        <ENT>3</ENT>
                        <ENT>0.17 (10 minutes)</ENT>
                        <ENT>0.51</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            3.6.4 
                            <SU>7</SU>
                        </ENT>
                        <ENT>3</ENT>
                        <ENT>2.67</ENT>
                        <ENT>8</ENT>
                        <ENT>0.25 (15 minutes)</ENT>
                        <ENT>2</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            3.7 
                            <SU>7</SU>
                        </ENT>
                        <ENT>4</ENT>
                        <ENT>2</ENT>
                        <ENT>8</ENT>
                        <ENT>0.08 (5 minutes)</ENT>
                        <ENT>0.64</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            4.2.3.2 
                            <SU>8</SU>
                        </ENT>
                        <ENT>5</ENT>
                        <ENT>25</ENT>
                        <ENT>125</ENT>
                        <ENT>0.17 (10 minutes)</ENT>
                        <ENT>21.25</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            4.2.3.2 
                            <SU>6</SU>
                        </ENT>
                        <ENT>5</ENT>
                        <ENT>0.20</ENT>
                        <ENT>1</ENT>
                        <ENT>0.17 (10 minutes)</ENT>
                        <ENT>0.17</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            4.2.3.3 and 4.3.2 
                            <SU>6</SU>
                        </ENT>
                        <ENT>5</ENT>
                        <ENT>0.20</ENT>
                        <ENT>1</ENT>
                        <ENT>0.17 (10 minutes)</ENT>
                        <ENT>0.17</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">4.3.1</ENT>
                        <ENT>3</ENT>
                        <ENT>1</ENT>
                        <ENT>3</ENT>
                        <ENT>0.25 (15 minutes)</ENT>
                        <ENT>0.75</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="01">
                            5.2 
                            <SU>9</SU>
                        </ENT>
                        <ENT>3</ENT>
                        <ENT>4</ENT>
                        <ENT>12</ENT>
                        <ENT>0.08 (5 minutes)</ENT>
                        <ENT>0.96</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Total</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>55.45</ENT>
                    </ROW>
                    <TNOTE>
                        <SU>1</SU>
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
                    </TNOTE>
                    <TNOTE>
                        <SU>2</SU>
                         A one-time burden for new respondents to set up a recordkeeping system linking all relevant records. FDA is using 1 new sponsor for estimation purposes.
                    </TNOTE>
                    <TNOTE>
                        <SU>3</SU>
                         FDA estimates there is minimal recordkeeping burden associated with maintaining the record system.
                    </TNOTE>
                    <TNOTE>
                        <SU>4</SU>
                         Monitoring for sentinel animals (subset representative of herd) plus all source animals. There are approximately 6 sentinel animals per herd × 1 herd per facility × 4 facilities = 24 sentinel animals. There are approximately 8 source animals per year (see footnote 7 of this table); 24 + 8 = 32 monitoring records to document.
                    </TNOTE>
                    <TNOTE>
                        <SU>5</SU>
                         Necropsy for animal deaths of unknown cause estimated to be approximately 2 per herd per year × 1 herd per facility × 4 facilities = 8.
                    </TNOTE>
                    <TNOTE>
                        <SU>6</SU>
                         Has not occurred in the past 3 years and is expected to continue to be a rare occurrence.
                    </TNOTE>
                    <TNOTE>
                        <SU>7</SU>
                         On average 2 source animals are used for preparing xenotransplantation product material for one recipient. The average number of source animals is 2 source animals per recipient × 4 recipients annually = 8 source animals per year. (See footnote 5 of table 6.)
                    </TNOTE>
                    <TNOTE>
                        <SU>8</SU>
                         FDA estimates there are 5 clinical centers doing xenotransplantation procedures × approximately 25 health care workers involved per center = 125 health care workers.
                    </TNOTE>
                    <TNOTE>
                        <SU>9</SU>
                         Eight source animal records + 4 recipient records = 12 total records.
                    </TNOTE>
                </GPOTABLE>
                <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s50,12,12,12,r50,12">
                    <TTITLE>
                        Table 6—Estimated Annual Third-Party Disclosure Burden 
                        <SU>1</SU>
                    </TTITLE>
                    <BOXHD>
                        <CHED H="1">PHS guideline section</CHED>
                        <CHED H="1">
                            Number of
                            <LI>respondents</LI>
                        </CHED>
                        <CHED H="1">
                            Number of
                            <LI>disclosures per</LI>
                            <LI>respondent</LI>
                        </CHED>
                        <CHED H="1">
                            Total annual
                            <LI>disclosures</LI>
                        </CHED>
                        <CHED H="1">Average burden per disclosure</CHED>
                        <CHED H="1">Total hours</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">
                            3.2.7.2 
                            <SU>2</SU>
                        </ENT>
                        <ENT>1</ENT>
                        <ENT>1</ENT>
                        <ENT>1</ENT>
                        <ENT>0.50 (30 minutes)</ENT>
                        <ENT>0.5</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            3.4 
                            <SU>3</SU>
                        </ENT>
                        <ENT>4</ENT>
                        <ENT>0.25</ENT>
                        <ENT>1</ENT>
                        <ENT>0.08 (5 minutes)</ENT>
                        <ENT>0.08</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            3.5.1 
                            <SU>4</SU>
                        </ENT>
                        <ENT>4</ENT>
                        <ENT>0.25</ENT>
                        <ENT>1</ENT>
                        <ENT>0.25 (15 minutes)</ENT>
                        <ENT>0.25</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            3.5.4 
                            <SU>5</SU>
                        </ENT>
                        <ENT>4</ENT>
                        <ENT>1</ENT>
                        <ENT>4</ENT>
                        <ENT>0.50 (30 minutes)</ENT>
                        <ENT>2.00</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="01">
                            3.5.5 
                            <SU>4</SU>
                        </ENT>
                        <ENT>4</ENT>
                        <ENT>0.25</ENT>
                        <ENT>1</ENT>
                        <ENT>0.25 (15 minutes)</ENT>
                        <ENT>0.25</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Total</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>3.08</ENT>
                    </ROW>
                    <TNOTE>
                        <SU>1</SU>
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
                    </TNOTE>
                    <TNOTE>
                        <SU>2</SU>
                         FDA is using one animal facility or sponsor for estimation purposes.
                    </TNOTE>
                    <TNOTE>
                        <SU>3</SU>
                         FDA's records indicate that an average of one IND is expected to be submitted per year.
                    </TNOTE>
                    <TNOTE>
                        <SU>4</SU>
                         To our knowledge, has not occurred in the past 3 years and is expected to continue to be a rare occurrence.
                    </TNOTE>
                    <TNOTE>
                        <SU>5</SU>
                         Based on an estimate of 12 patients treated over a 3 year period, the average number of xenotransplantation product recipients per year is estimated to be 4.
                    </TNOTE>
                </GPOTABLE>
                <P>
                    Because of the potential risk for cross-species transmission of pathogenic persistent virus, the guideline recommends that health records be retained for 50 years. Since these records are medical records, the retention of such records for up to 50 years is not information subject to the PRA (5 CFR 1320.3(h)(5)). Also, because of the limited number of clinical studies with small patient populations, the number of records is expected to be insignificant at this time. Information collections in this guideline not included in tables 1 through 6 can be found under existing regulations and approved under the OMB control numbers as follows: (1) “Current Good Manufacturing Practice for Finished Pharmaceuticals,” 21 CFR 211.1 through 211.208, approved under OMB control number 0910-0139; (2) “Investigational New Drug Application,” 21 CFR 312.1 through 312.160, approved under OMB control number 0910-0014; and (3) information included in a biologics license application, 21 CFR 601.2, approved under OMB control number 0910-0338. (Although it is possible that a xenotransplantation product may not be regulated as a biological product (
                    <E T="03">e.g.,</E>
                     it may be regulated as a medical device), FDA believes, based on its knowledge and experience with xenotransplantation, that any xenotransplantation product subject to FDA regulation within the next 3 years will most likely be regulated as a biological product.). However, FDA recognized that some of the information collections go beyond approved collections; assessments for these burdens are included in tables 1 through 6.
                </P>
                <P>
                    In table 7, FDA identifies those collection of information activities that are already encompassed by existing regulations or are consistent with 
                    <PRTPAGE P="58670"/>
                    voluntary standards which reflect industry's usual and customary business practice.
                </P>
                <GPOTABLE COLS="3" OPTS="L2,nj,i1" CDEF="s50,r100,r75">
                    <TTITLE>Table 7—Collection of Information Required by Current Regulations and Standards</TTITLE>
                    <BOXHD>
                        <CHED H="1">PHS guideline section</CHED>
                        <CHED H="1">Description</CHED>
                        <CHED H="1">
                            21 CFR section
                            <LI>(unless otherwise stated)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">2.2.1</ENT>
                        <ENT>Document offsite collaborations</ENT>
                        <ENT>312.52.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">2.5</ENT>
                        <ENT>Sponsor ensures counseling patient + family + contacts</ENT>
                        <ENT>312.62(c).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.1.1 and 3.1.6</ENT>
                        <ENT>Document well-characterized health history and lineage of source animals</ENT>
                        <ENT>312.23(a)(7)(a) and 211.84.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.1.8</ENT>
                        <ENT>Registration with and import permit from the Centers for Disease Control and Prevention</ENT>
                        <ENT>42 CFR 71.53.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.2.2</ENT>
                        <ENT>Document collaboration with accredited microbiology labs</ENT>
                        <ENT>312.52.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.2.3</ENT>
                        <ENT>Procedures to ensure the humane care of animals</ENT>
                        <ENT>
                            9 CFR parts 1, 2, and 3 and PHS Policy.
                            <SU>1</SU>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.2.4</ENT>
                        <ENT>Procedures consistent for accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International) and consistent with the National Research Council's (NRC) Guide</ENT>
                        <ENT>
                            AAALAC International Rules of Accreditation 
                            <SU>2</SU>
                             and NRC Guide.
                            <SU>3</SU>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.2.5, 3.4, and 3.4.1</ENT>
                        <ENT>Herd health maintenance and surveillance to be documented, available, and in accordance with documented procedures; record standard veterinary care</ENT>
                        <ENT>211.100 and 211.122.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.2.6</ENT>
                        <ENT>Animal facility SOPs</ENT>
                        <ENT>
                            PHS Policy.
                            <SU>1</SU>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.3.3</ENT>
                        <ENT>Validate assay methods</ENT>
                        <ENT>211.160(a)</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.6.1</ENT>
                        <ENT>Procurement and processing of xenografts using documented aseptic conditions</ENT>
                        <ENT>211.100 and 211.122.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.6.2</ENT>
                        <ENT>Develop, implement, and enforce SOPs for procurement and screening processes</ENT>
                        <ENT>211.84(d) and 211.122(c).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.6.4</ENT>
                        <ENT>Communicate to FDA animal necropsy findings pertinent to health of recipient</ENT>
                        <ENT>312.32(c).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3.7.1</ENT>
                        <ENT>PHS specimens to be linked to health records; provide to FDA justification for types of tissues, cells, and plasma, and quantities of plasma and leukocytes collected</ENT>
                        <ENT>312.23(a)(6).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">4.1.1</ENT>
                        <ENT>Surveillance of xenotransplant recipient; sponsor ensures documentation of surveillance program life-long (justify &gt;2 yrs.); investigator case histories (2 yrs. after investigation is discontinued)</ENT>
                        <ENT>312.23(a)(6)(iii)(f) and (g), and 312.62(b) and (c).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">4.1.2</ENT>
                        <ENT>Sponsor to justify amount and type of reserve samples</ENT>
                        <ENT>211.122.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">4.1.2.2</ENT>
                        <ENT>System for prompt retrieval of PHS specimens and linkage to medical records (recipient and source animal)</ENT>
                        <ENT>312.57(a).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">4.1.2.3</ENT>
                        <ENT>Notify FDA of a clinical episode potentially representing a xenogeneic infection</ENT>
                        <ENT>312.32.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">4.2.2.1</ENT>
                        <ENT>Document collaborations (transfer of obligation)</ENT>
                        <ENT>312.52.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">4.2.3.1</ENT>
                        <ENT>Develop educational materials (sponsor provides investigators with information needed to conduct investigation properly)</ENT>
                        <ENT>312.50.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">4.3</ENT>
                        <ENT>Sponsor to keep records of receipt, shipment, and disposition of investigative drug; investigator to keep records of case histories</ENT>
                        <ENT>312.57 and 312.62(b).</ENT>
                    </ROW>
                    <TNOTE>
                        <SU>1</SU>
                         The “Public Health Service Policy on Humane Care and Use of Laboratory Animals” (
                        <E T="03">https://olaw.nih.gov/policies-laws/phs-policy.htm</E>
                        ).
                    </TNOTE>
                    <TNOTE>
                        <SU>2</SU>
                         AAALAC International Rules of Accreditation (
                        <E T="03">https://www.aaalac.org/accreditation-program/rules-of-accreditation/</E>
                        ).
                    </TNOTE>
                    <TNOTE>
                        <SU>3</SU>
                         The NRC's “Guide for the Care and Use of Laboratory Animals.”
                    </TNOTE>
                </GPOTABLE>
                <P>Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate other than to adjust total burden hours by one hour, from 60 to 59 total burden hours, to address an inadvertent error in disclosure burden in the previous submissions to OMB.</P>
                <SIG>
                    <DATED>Dated: October 15, 2021.</DATED>
                    <NAME>Lauren K. Roth,</NAME>
                    <TITLE>Associate Commissioner for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23086 Filed 10-21-21; 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-2020-E-1910]</DEPDOC>
                <SUBJECT>Determination of Regulatory Review Period for Purposes of Patent Extension; NUBEQA</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Food and Drug Administration, HHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NUBEQA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        Anyone with knowledge that any of the dates as published (see 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                        ) are incorrect may submit either electronic or written comments and ask for a redetermination by December 21, 2021. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by 
                        <PRTPAGE P="58671"/>
                        April 20, 2022. See “Petitions” in the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section for more information.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 21, 2021. The 
                        <E T="03">https://www.regulations.gov</E>
                         electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 21, 2021. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
                    </P>
                </ADD>
                <HD SOURCE="HD2">Electronic Submissions</HD>
                <P>Submit electronic comments in the following way:</P>
                <P>
                    • 
                    <E T="03">Federal eRulemaking Portal:</E>
                      
                    <E T="03">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-2020-E-1910 for “Determination of Regulatory Review Period for Purposes of Patent Extension; NUBEQA.” Received comments, those filed in a timely manner (see 
                    <E T="02">ADDRESSES</E>
                    ), 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 § 10.20 (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>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.</P>
                <P>A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).</P>
                <P>FDA has approved for marketing the human drug product, NUBEQA (darolutamide), indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer. Subsequent to this approval, the USPTO received a patent term restoration application for NUBEQA (U.S. Patent No. 8,975,254) from Orion Corporation, and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated May 24, 2021, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of NUBEQA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.</P>
                <HD SOURCE="HD1">II. Determination of Regulatory Review Period</HD>
                <P>
                    FDA has determined that the applicable regulatory review period for 
                    <PRTPAGE P="58672"/>
                    NUBEQA is 2,576 days. Of this time, 2,420 days occurred during the testing phase of the regulatory review period, while 156 days occurred during the approval phase. These periods of time were derived from the following dates:
                </P>
                <P>
                    1. 
                    <E T="03">The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act) (21 U.S.C. 355(i)) became effective:</E>
                     July 13, 2012. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on July 13, 2012.
                </P>
                <P>
                    2. 
                    <E T="03">The date the application was initially submitted with respect to the human drug product under section 505 of the FD&amp;C Act:</E>
                     February 26, 2019. FDA has verified the applicant's claim that the new drug application (NDA) for NUBEQA (NDA 212099) was initially submitted on February 26, 2019.
                </P>
                <P>
                    3. 
                    <E T="03">The date the application was approved:</E>
                     July 30, 2019. FDA has verified the applicant's claim that NDA 212099 was approved on July 30, 2019.
                </P>
                <P>This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 879 days of patent term extension.</P>
                <HD SOURCE="HD1">III. Petitions</HD>
                <P>
                    Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see 
                    <E T="02">DATES</E>
                    ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see 
                    <E T="02">DATES</E>
                    ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.
                </P>
                <P>
                    Submit petitions electronically to 
                    <E T="03">https://www.regulations.gov</E>
                     at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
                </P>
                <SIG>
                    <DATED>Dated: October 15, 2021.</DATED>
                    <NAME>Lauren K. Roth,</NAME>
                    <TITLE>Associate Commissioner for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23074 Filed 10-21-21; 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-2021-D-0548]</DEPDOC>
                <SUBJECT>Data Standards for Drug and Biological Product Submissions Containing Real-World Data; 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 “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.” This guidance provides recommendations to sponsors to help support compliance with the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act) when submitting study data derived from real-world data (RWD) sources in applicable regulatory submissions using standards specified in the Data Standards Catalog (Catalog). FDA is publishing this draft guidance as part of a series of guidance documents under its program to evaluate the use of real-world evidence (RWE) in regulatory decision making.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit either electronic or written comments on the draft guidance by December 21, 2021 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>
                    <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-2021-D-0548 for “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.” 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 
                    <PRTPAGE P="58673"/>
                    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, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, 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. 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>
                        Dianne Paraoan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 51, Rm. 3326, Silver Spring, MD 20993-0002, 301-796-3161, 
                        <E T="03">Dianne.Paraoan@fda.hhs.gov,</E>
                         or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 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 draft guidance for industry entitled “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.” Under section 745A(a) of the FD&amp;C Act (21 U.S.C. 379k-1(a)) and the guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Standardized Study Data” (Study Data Guidance), clinical or nonclinical study data contained in new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) must be in an electronic format that the Agency can process, review, and archive, unless such submission is exempt from the electronic submission requirements or if FDA has granted a waiver. This guidance clarifies that RWD submitted as study data in NDAs, ANDAs, certain BLAs, and certain INDs are subject to the requirements in section 745A(a) of the FD&amp;C Act (21 U.S.C. 379k-1(a)) and the Study Data Guidance. Currently, as stated in the Study Data Guidance, the Agency can process, review, and archive electronic submissions of clinical and nonclinical study data (including data derived from RWD sources) that use the standards specified in the Catalog posted to FDA's Study Data Standards Resources web page (
                    <E T="03">https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources</E>
                    ). Therefore, submissions subject to section 745A(a) of the FD&amp;C Act that contain study data derived from RWD sources must be in electronic format using the study data standards currently supported by FDA as specified in the Catalog. This guidance provides recommendations to sponsors for complying with section 745A(a) of the FD&amp;C Act when submitting study data derived from RWD sources in an applicable regulatory submission using standards specified in the Catalog.
                </P>
                <P>Section 3022 of the 21st Century Cures Act (Cures Act) amended the FD&amp;C Act to add section 505F, Utilizing Real World Evidence (21 U.S.C. 355g). This section requires the establishment of a program to evaluate the potential use of RWE to help support the approval of a new indication for a drug approved under section 505(c) of the FD&amp;C Act (21 U.S.C. 355(c)) and to help support or satisfy postapproval study requirements. This section also requires that FDA use the program to inform guidance for industry on the circumstances under which sponsors of drugs may rely on RWE and the appropriate standards and methodologies for collection and analysis of RWE submitted to evaluate the potential use of RWE for those purposes. Further, under the Prescription Drug User Fee Amendments of 2017 (PDUFA VI), FDA committed to publishing draft guidance on how RWE can contribute to the assessment of safety and effectiveness in regulatory submissions. FDA is issuing the draft guidance entitled “Data Standards for Drug and Biological Product Submissions Containing Real-World Data” as part of a series of guidance documents to satisfy the Cures Act mandate and the PDUFA VI commitment.</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 “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.” 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 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 part 314 (Applications for FDA Approval to Market a New Drug) have been approved under OMB control number 0910-0001; the collections of information in 21 CFR part 312 (Investigational New Drug Regulations) have been approved under OMB control number 0910-0014; the collections of information in 21 CFR part 58 (Good Laboratory Practice Regulations for Nonclinical Laboratory Studies) have been approved under OMB control number 0910-0119; and the collections of information in 21 CFR part 601 (General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension) have been approved under OMB control number 0910-0338.</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/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,</E>
                     or 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <SIG>
                    <PRTPAGE P="58674"/>
                    <DATED>Dated: October 8, 2021.</DATED>
                    <NAME>Lauren K. Roth,</NAME>
                    <TITLE>Associate Commissioner for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23081 Filed 10-21-21; 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-2021-N-1038]</DEPDOC>
                <SUBJECT>Determination That ROBAXIN and ROBAXIN-750 (Methocarbamol), Oral Tablets, 500 Milligrams and 750 Milligrams, and Other Drug Products, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Food and Drug Administration, HHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, 
                        <E T="03">Stacy.Kane@fda.hhs.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) Has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).</P>
                <P>Section 505(j)(7) of the FD&amp;C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).</P>
                <P>Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug.</P>
                <P>FDA has become aware that the drug products listed in the table are no longer being marketed.</P>
                <GPOTABLE COLS="6" OPTS="L2,nj,tp0,i1" CDEF="xs54,r50,r50,r50,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Application No.</CHED>
                        <CHED H="1">Drug name</CHED>
                        <CHED H="1">Active ingredient(s)</CHED>
                        <CHED H="1">Strength(s)</CHED>
                        <CHED H="1">Dosage form/route</CHED>
                        <CHED H="1">Applicant</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">NDA 011011</ENT>
                        <ENT>ROBAXIN; ROBAXIN-750</ENT>
                        <ENT>Methocarbamol</ENT>
                        <ENT>500 milligrams (mg); 750 mg</ENT>
                        <ENT>Tablet; Oral</ENT>
                        <ENT>Auxilium Pharmaceuticals LLC.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 018704</ENT>
                        <ENT>LOPRESSOR</ENT>
                        <ENT>Metoprolol Tartrate</ENT>
                        <ENT>1 mg/milliliter (mL)</ENT>
                        <ENT>Injectable; Injection</ENT>
                        <ENT>Novartis.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 018917</ENT>
                        <ENT>SECTRAL</ENT>
                        <ENT>Acebutolol Hydrochloride</ENT>
                        <ENT>Equivalent to (EQ) 200 mg base; EQ 400 mg base</ENT>
                        <ENT>Capsule; Oral</ENT>
                        <ENT>Promius Pharma, LLC.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 019546</ENT>
                        <ENT>DYNACIRC</ENT>
                        <ENT>Isradipine</ENT>
                        <ENT>2.5 mg; 5 mg</ENT>
                        <ENT>Capsule; Oral</ENT>
                        <ENT>SmithKline Beecham.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 019555</ENT>
                        <ENT>DIPROLENE AF</ENT>
                        <ENT>Betamethasone Dipropionate</ENT>
                        <ENT>EQ 0.05% base</ENT>
                        <ENT>Cream, Augmented; Topical</ENT>
                        <ENT>Merck Sharp Dohme.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 019625</ENT>
                        <ENT>ELOCON</ENT>
                        <ENT>Mometasone Furoate</ENT>
                        <ENT>0.10%</ENT>
                        <ENT>Cream; Topical</ENT>
                        <ENT>Merck Sharp Dohme.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 020089</ENT>
                        <ENT>ZOVIRAX</ENT>
                        <ENT>Acyclovir</ENT>
                        <ENT>400 mg; 800 mg</ENT>
                        <ENT>Tablet; Oral</ENT>
                        <ENT>Mylan.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 020136</ENT>
                        <ENT>DEMADEX</ENT>
                        <ENT>Torsemide</ENT>
                        <ENT>5 mg; 10 mg; 20 mg; 100 mg</ENT>
                        <ENT>Tablet; Oral</ENT>
                        <ENT>Mylan Specialty, L.P.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 020198</ENT>
                        <ENT>ADALAT CC</ENT>
                        <ENT>Nifedipine</ENT>
                        <ENT>30 mg; 60 mg; 90 mg</ENT>
                        <ENT>Tablet, Extended Release; Oral</ENT>
                        <ENT>Alvogen.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 020539</ENT>
                        <ENT>LAMISIL</ENT>
                        <ENT>Terbinafine Hydrochloride</ENT>
                        <ENT>EQ 250 mg base</ENT>
                        <ENT>Tablet; Oral</ENT>
                        <ENT>Novartis.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 020634</ENT>
                        <ENT>LEVAQUIN</ENT>
                        <ENT>Levofloxacin</ENT>
                        <ENT>250 mg; 500 mg; 750 mg</ENT>
                        <ENT>Tablet; Oral</ENT>
                        <ENT>Janssen Research &amp; Development, LLC.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 020716</ENT>
                        <ENT>VICOPROFEN</ENT>
                        <ENT>Hydrocodone Bitartrate; Ibuprofen</ENT>
                        <ENT>7.5 mg; 200 mg</ENT>
                        <ENT>Tablet; Oral</ENT>
                        <ENT>Abbvie, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 020738</ENT>
                        <ENT>TEVETEN</ENT>
                        <ENT>Eprosartan Mesylate</ENT>
                        <ENT>EQ 300 mg base; EQ 400 mg base; EQ 600 mg base</ENT>
                        <ENT>Tablet; Oral</ENT>
                        <ENT>Abbvie, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 021001</ENT>
                        <ENT>AXERT</ENT>
                        <ENT>Almotriptan Malate</ENT>
                        <ENT>EQ 6.25 mg base; EQ 12.5 mg base</ENT>
                        <ENT>Tablet; Oral</ENT>
                        <ENT>Janssen Pharms.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 022205</ENT>
                        <ENT>GIAZO</ENT>
                        <ENT>Balsalazide Disodium</ENT>
                        <ENT>1.1 gram</ENT>
                        <ENT>Tablets; Oral</ENT>
                        <ENT>Valeant Pharms. International.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 022439</ENT>
                        <ENT>ZUTRIPRO</ENT>
                        <ENT>Chlorpheniramine Maleate, Hydrocodone Bitartrate, and Pseudoephedrine Hydrochloride</ENT>
                        <ENT>4 mg/5 mL; 5 mg/5 mL; 60 mg/5 mL</ENT>
                        <ENT>Solution; Oral</ENT>
                        <ENT>Persion Pharms, LLC.</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="58675"/>
                        <ENT I="01">NDA 022510</ENT>
                        <ENT>ABSTRAL</ENT>
                        <ENT>Fentanyl Citrate</ENT>
                        <ENT>EQ 0.1 mg base; EQ 0.2 mg base; EQ 0.3 mg base; EQ 0.4 mg base; EQ 0.6 mg base; EQ 0.8 mg base</ENT>
                        <ENT>Tablet; Sublingual</ENT>
                        <ENT>Sentynl Therapeutics, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 050011</ENT>
                        <ENT>PATHOCIL</ENT>
                        <ENT>Dicloxacillin Sodium</ENT>
                        <ENT>EQ 250 mg base; EQ 500 mg base</ENT>
                        <ENT>Capsule; Oral</ENT>
                        <ENT>Wyeth-Ayerst Labs.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 204308</ENT>
                        <ENT>EPANED KIT</ENT>
                        <ENT>Enalapril Maleate</ENT>
                        <ENT>1 mg/mL</ENT>
                        <ENT>For Solution; Oral</ENT>
                        <ENT>Silvergate Pharms., Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 207233</ENT>
                        <ENT>VIVLODEX</ENT>
                        <ENT>Meloxicam</ENT>
                        <ENT>5 mg; 10 mg</ENT>
                        <ENT>Capsule; Oral</ENT>
                        <ENT>Zyla.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>FDA has reviewed its records and, under § 314.161, has determined that the drug products listed were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products in the “Discontinued Drug Product List” section of the Orange Book. The Discontinued Drug Product List identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness.</P>
                <P>Approved ANDAs that refer to the NDAs listed are unaffected by the discontinued marketing of the products subject to those NDAs. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.</P>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>Lauren K. Roth,</NAME>
                    <TITLE>Associate Commissioner for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23084 Filed 10-21-21; 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-2021-N-1037]</DEPDOC>
                <SUBJECT>Fresenius USA, Inc., et al.; Withdrawal of Approval of 216 Abbreviated New Drug Applications</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Food and Drug Administration, Health and Human Services (HHS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Food and Drug Administration (FDA or Agency) is withdrawing approval of 216 abbreviated new drug applications (ANDAs) from multiple holders of those ANDAs. The basis for the withdrawal is that these ANDA holders have repeatedly failed to submit required annual reports for those ANDAs.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Approval is withdrawn as of November 22, 2021.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        James Hanratty, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-4718, 
                        <E T="03">James.Hanratty@fda.hhs.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The holders of an approved application to market a new drug for human use are required to submit annual reports to FDA concerning their approved application in accordance with §§ 314.81 and 314.98 (21 CFR 314.81 and 314.98). In the 
                    <E T="04">Federal Register</E>
                     of January 9, 2020 (85 FR 1160), FDA published a notice offering an opportunity for a hearing (NOOH) on a proposal to withdraw approval of 249 ANDAs because the holders of those ANDAs had repeatedly failed to submit the required annual reports for those ANDAs (“Fresenius USA, Inc., et al.; Proposal To Withdraw Approval of 249 Abbreviated New Drug Applications; Opportunity for a Hearing”).
                    <SU>1</SU>
                    <FTREF/>
                     The holder of ANDA 085882, ANDA 086262, and ANDA 0866263 responded to the NOOH and requested a hearing. The remaining holders of those ANDAs did not respond to the NOOH. Failure to file a written notice of participation and request for hearing as required by § 314.200 constitutes an election by those holders of the ANDAs not to make use of the opportunity for a hearing concerning the proposal to withdraw approval of their ANDAs and a waiver of any contentions concerning the legal status of the drug products. Therefore, FDA is withdrawing approval of the 216 applications listed in table 1.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         85 FR 1160, published on January 9, 2020, incorrectly listed 249 as the number of the ANDAs FDA proposed to withdrawal. 85 FR 1160 listed 248 ANDAs in the table included in the notice.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Annual Reports Submitted</HD>
                <P>In response to the NOOH, one firm requested a hearing and had previously submitted an annual report for each of its three ANDAs. Therefore, FDA rescinds its proposal to withdraw approval of the following three ANDAs:</P>
                <FP SOURCE="FP-1">Chartwell RX Sciences, LLC, 77 Brenner Dr., Congers, NY 10920:</FP>
                <FP SOURCE="FP-1">• ANDA 085882, DUVOID (bethanechol chloride) Tablets, 50 milligrams (mg)</FP>
                <FP SOURCE="FP-1">• ANDA 086262, DUVOID (bethanechol chloride) Tablets, 10 mg</FP>
                <FP SOURCE="FP-1">• ANDA 086263, DUVOID (bethanechol chloride) Tablets, 25 mg</FP>
                <P>Another three firms notified the Agency that they had submitted an annual report for each of its ANDAs listed in the NOOH. Therefore, FDA rescinds its proposal to withdraw approval of the following eight ANDAs:</P>
                <P>Jerome Stevens Pharmaceuticals Inc., 60 DaVinci Dr., Bohemia, NY 11716:</P>
                <FP SOURCE="FP-1">• ANDA 062869, CEPHALEXIN Capsules USP, EQ 500 mg base</FP>
                <FP SOURCE="FP-1">• ANDA 062870, CEPHALEXIN Capsules USP, EQ 250 mg base</FP>
                <FP SOURCE="FP-1">• ANDA 074988, ASPIRIN, CAFFEINE, AND ORPHENADRINE CITRATE Tablets, 385 mg/30 mg/25 mg, and 770 mg/60 mg/50 mg</FP>
                <FP SOURCE="FP-1">• ANDA 081145, ASPIRIN AND METHOCARBAMOL Tablets, 325 mg/400 mg</FP>
                <P>MIPS Cyclotron and Radiochemistry Facility, 1201 Welch Rd., Rm. PS049, Stanford, CA 94305:</P>
                <FP SOURCE="FP-1">• ANDA 204472, FLUDEOXYGLUCOSE F-18 Injection USP, 20-300 millicuries (mCi)/milliliters (mL)</FP>
                <FP SOURCE="FP-1">• ANDA 204517, SODIUM FLUORIDE F-18 Injection, 10-200 mCi/mL</FP>
                <FP SOURCE="FP-1">• ANDA 204535, AMMONIA N-13 Injection USP, 3.75-37.5 mCi/mL</FP>
                <P>Milex Products, Inc., 5915 Northwest Hwy., Chicago, IL 60631:</P>
                <FP SOURCE="FP-1">• ANDA 072196, MILOPHENE (clomiphene citrate) Tablets, 50 mg</FP>
                <HD SOURCE="HD1">II. Previously Consolidated Application</HD>
                <P>
                    Sandoz, Inc., 4700 Eon Dr., Wilson, NC 27893, notified the Agency that ANDA 084631, QUINIDINE SULFATE Tablets USP, 200 mg, had previously been consolidated with ANDA 088072. Therefore, FDA rescinds its proposal to withdraw approval of this ANDA.
                    <PRTPAGE P="58676"/>
                </P>
                <HD SOURCE="HD1">III. Previously Transferred Application</HD>
                <P>Pfizer Laboratories, Division of Pfizer, Inc., 235 East 42nd St., New York, NY 10017, notified the Agency that ANDA 060074, PENICILLIN G POTASSIUM for Injection, 20,000,000 units/vial, had previously been transferred to Cultor Food Science, Inc. Therefore, FDA rescinds its proposal to withdraw approval of this ANDA.</P>
                <HD SOURCE="HD1">IV. Requests To Withdraw Approval</HD>
                <P>In response to the NOOH, 13 firms notified the Agency that they no longer market 15 of the ANDAs listed in the NOOH and had previously submitted written requests for withdrawal for the following ANDAs:</P>
                <P>1. Parkedale Pharmaceuticals, Inc., 501 5th St., Bristol, TN 37620, notified the Agency that they no longer market the product for ANDA 060521, HUMATIN (paromomycin sulfate) Capsules USP, Equivalent to (EQ) 250 mg base. On May 12, 2021 (86 FR 26058), the Agency withdrew approval of this ANDA at the written request of the applicant.</P>
                <P>2. Roerig Division of Pfizer Inc., 235 East 42nd St., New York, NY 10017, notified the Agency that they no longer market the product for ANDA 060709, OLEANDOMYCIN Injection. On July 21, 2020 (85 FR 44096), the Agency withdrew approval of this ANDA under the written request of the applicant.</P>
                <P>3. Pharmacia and Upjohn Co., 7171 Portage Rd., Kalamazoo, MI 49001, notified the Agency that they no longer market the product for ANDA 061034, LINCOMYCIN HYDROCHLORIDE (HCl) Powder. On May 12, 2021, the Agency withdrew approval of this ANDA under the written request of the applicant.</P>
                <P>4. Lederle Laboratories, Division of American Cyanamid Co., 401 North Middletown Rd., Pearl River, NY 10965, notified the Agency that they no longer market the product for ANDA 061064, NYSTATIN Ointment. On May 12, 2021, the Agency withdrew approval of this ANDA under the written request of the applicant.</P>
                <P>5. Pfizer Laboratories, Division of Pfizer Inc., 235 East 42nd St., New York, NY 10017, notified the Agency that they no longer market the product for ANDA 061087, BENZOCAINE, OXYTETRACYCLINE HCl, and POLYMYXIN B SULFATE OTIC Solution. On July 21, 2020, the Agency withdrew approval of this ANDA under the written request of the applicant.</P>
                <P>6. Warner-Lambert Co., 201 Tabor Rd., Morris Plains, NJ 07950, notified the Agency that they no longer market the product for ANDA 061652, OXYTETRACYCLINE Capsules. On May 12, 2021, the Agency withdrew approval of this ANDA under the written request of the applicant.</P>
                <P>7. AH Robins Co., 1211 Sherwood Ave., Richmond, VA 23220, notified the Agency that they no longer market the product for ANDA 061701, TETRACYCLINE Syrup, 125 mg/5 mL. On May 12, 2021, the Agency withdrew approval of this ANDA under the written request of the applicant.</P>
                <P>8. Warner Chilcott, Division of Warner Lambert-Pfizer, Inc., 235 East 42nd St., New York, NY 10017, notified the Agency that they no longer market the products for ANDA 061725, TETRACYCLINE HCl Capsules, 250 mg and 500 mg, and ANDA 062175, TETRACYCLINE HCl Capsules, 250 mg. On July 21, 2020, the Agency withdrew approval of these ANDAs under the written request of the applicant.</P>
                <P>9. Lederle Laboratories, Division of American Cyanamid Co., 1 Cyanamid Plaza, Wayne, NJ 07470, notified the Agency that they no longer market the products for ANDA 061943, CHLORAMPHENICOL Ophthalmic Solution, 0.5 percent; ANDA 062215, OXYTETRACYCLINE HCl Capsules. On July 21, 2020, the Agency withdrew approval of these ANDAs under the written request of the applicant.</P>
                <P>10. Warner-Lambert Co. notified the Agency that they no longer market the product for ANDA 062032, EYPAR (erythromycin stearate) Tablets, EQ 250 mg base and EQ 500 mg base. On May 12, 2021, the Agency withdrew approval of this ANDA under the written request of the applicant.</P>
                <P>11. Becton Dickinson and Co., Surgical System, 9450 South State St., Sandy, UT 84070, notified the Agency that they no longer market the product for ANDA 073416, E-Z SCRUB (chlorhexidine gluconate) Topical Sponge, 4 percent. On January 8, 2020 (85 FR 909), the Agency withdrew approval of this ANDA under the written request of the applicant.</P>
                <P>12. Lederle Laboratories, Division of American Cyanamid Co., Pearl River, NY 10965-1215, notified the Agency that they no longer market the products for ANDA 083001, TRIAMCINOLONE ACETONIDE Aerosol Foam Emulsion. On May 12, 2021, the Agency withdrew approval of this ANDA under the written request of the applicant.</P>
                <P>13. Lederle Laboratories, Division of American Cyanamid Co., Pearl River, NY 10965-1215, notified the Agency that they no longer market the product for ANDA 084803, CHLORPROMAZINE HCl Tablets, 10 mg. On May 12, 2021, the Agency withdrew approval of this ANDA under the written request of the applicant.</P>
                <HD SOURCE="HD1">V. Previously Withdrawn Applications</HD>
                <P>
                    In the 
                    <E T="04">Federal Register</E>
                     of September 25, 2020 (85 FR 60474), FDA published a separate notice offering an opportunity for a hearing (NOOH) on a proposal to withdraw approval of ANDAs because the holders of those ANDAs had repeatedly failed to submit the required annual reports and have failed to satisfy the requirement to have an approved risk evaluation and mitigation strategy for the following ANDAs:
                </P>
                <P>1. Everylife, 2021 15th Avenue West, Seattle, WA 98119: ANDA 085217, ACETAMINOPHEN and CODEINE PHOSPHATE Tablet, 325 mg/30 mg.</P>
                <P>2. Scherer Laboratories, Inc., 2301 Ohio Dr., Suite 234, Plano, TX 75093: ANDA 085638, ACETAMINOPHEN, ASPIRIN, and CODEINE, 150 mg/180 mg/60 mg; ANDA 085639, ACETAMINOPHEN, ASPIRIN, and CODEINE PHOSPHATE Capsule, 150 mg/180 mg/30 mg; ANDA 085640, ACETAMINOPHEN, ASPIRIN, and CODEINE PHOSPHATE Capsule, 150 mg/180 mg/15 mg.</P>
                <P>
                    The holders of the applications did not respond to the 
                    <E T="04">Federal Register</E>
                     NOOH of September 25, 2020. Failure to submit a written notice of participation and request for hearing as required by § 314.200 constitutes an election by those holders not to make use of the opportunity for a hearing concerning the proposal to withdraw approval of their ANDAs and a waiver of any contentions concerning the legal status of the drug products. On April 9, 2021 (86 FR 18542), the Agency withdrew approval of these ANDAs.
                </P>
                <HD SOURCE="HD1">VI. No Response to NOOH Received</HD>
                <P>
                    The holders of the other 216 applications did not respond to the NOOH. Failure to submit a written notice of participation and request for hearing as required by § 314.200 constitutes an election by those holders not to make use of the opportunity for a hearing concerning the proposal to withdraw approval of their ANDAs and a waiver of any contentions concerning the legal status of the drug products. Therefore, the Director, Center for Drug Evaluation and Research, is withdrawing approval of the 216 applications listed in table 1.
                    <PRTPAGE P="58677"/>
                </P>
                <GPOTABLE COLS="3" OPTS="L2,nj,i1" CDEF="xs72,r100,r100">
                    <TTITLE>Table 1—Approved ANDAs for Which Required Reports Have Not Been Submitted</TTITLE>
                    <BOXHD>
                        <CHED H="1">Application No.</CHED>
                        <CHED H="1">Drug</CHED>
                        <CHED H="1">Applicant</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">ANDA 020374</ENT>
                        <ENT>Inpersol-LC/LM with Dextrose 1.5% (calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate) Intraperitoneal Solution, 18.4 mg/100 mL; 1.5 grams (g)/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL</ENT>
                        <ENT>Fresenius USA, Inc., 2637 Shadelands Dr., Walnut Creek, CA 94598.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Inpersol-LC/LM with Dextrose 2.5% (calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate) Intraperitoneal Solution, 18.4 mg/100 mL; 2.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Inpersol-LC/LM with Dextrose 3.5% (calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate) Intraperitoneal Solution, 18.4 mg/100 mL; 3.5 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Inpersol-LC/LM with Dextrose 4.25% (calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate) Intraperitoneal Solution, 18.4 mg/100 mL; 4.25 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 040057</ENT>
                        <ENT>Epinephrine and Lidocaine Hydrochloride (HCl) Injection, 0.01 mg/mL; 2% and 0.02 mg/mL; 2%</ENT>
                        <ENT>Eastman Kodak Co., 343 State St., Rochester, NY 14650.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 040168</ENT>
                        <ENT>Hydrocortisone and Acetic Acid Otic Solution USP, 1%/2%</ENT>
                        <ENT>Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc., 6451 West Main St., Morton Grove, IL 60053.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 040192</ENT>
                        <ENT>Prednisolone Syrup, 15 mg/5 mL</ENT>
                        <ENT>WE Pharmaceuticals, Inc., 1142 D St., P.O. Box 1142, Ramona, CA 92065.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 060131</ENT>
                        <ENT>Tetracycline HCl Capsules</ENT>
                        <ENT>Leiner Health Products, Inc., 901 East 233rd St., Carson, CA 90745.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 060461</ENT>
                        <ENT>Neomycin Sulfate Ointment; Neomycin Sulfate and Hydrocortisone Acetate Ointment</ENT>
                        <ENT>Ambix Laboratories, Division of Organics Corp. of America, 210 Orchard St., East Rutherford, NJ 07073.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 060602</ENT>
                        <ENT>Penicillin G Potassium Powder</ENT>
                        <ENT>John D. Copanos and Co., Inc., 6110 Robinwood Rd., Baltimore, MD 21225.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 060627</ENT>
                        <ENT>Tribiotic (polymyxin B sulfate, bacitracin, and neomycin sulfate) Ointment, 5000 units/400 units/5 mg</ENT>
                        <ENT>Ambix Laboratories, Division of Organics Corp. of America.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 060724</ENT>
                        <ENT>Pyocidin-HC (neomycin sulfate, polymyxin B sulfate, and hydrocortisone) Otic Solution</ENT>
                        <ENT>Kasco-EFCO Laboratories, Inc., Cantiague Rock Rd., Hicksville, NY 11802.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 060769</ENT>
                        <ENT>Tetracycline Syrup</ENT>
                        <ENT>West-Ward Pharmaceutical Corp., 465 Industrial Way West, Eatontown, NJ 07724.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 060773</ENT>
                        <ENT>Tetracycline Syrup</ENT>
                        <ENT>Leiner Health Products, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 060870</ENT>
                        <ENT>Oxytetracycline Injection</ENT>
                        <ENT>Proter S.p.A., c/o Richmar International, Inc., 1706 Birch Rd., McLean, VA 22101.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 061154</ENT>
                        <ENT>Hydrocortisone Acetate and Neomycin Sulfate Ointment</ENT>
                        <ENT>Ambix Laboratories, Division of Organics Corp. of America.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 061209</ENT>
                        <ENT>Bacitracin Ointment USP, 500 units/g</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 061228</ENT>
                        <ENT>Griseofulvin Capsules</ENT>
                        <ENT>Owen Laboratories, Division of Alcon Laboratories, 3737 Beltline Rd., Dallas, TX 75234.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 061483</ENT>
                        <ENT>Penicillin G Potassium Tablets</ENT>
                        <ENT>Leiner Health Products, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 061518</ENT>
                        <ENT>Bacitracin Zinc Ointment</ENT>
                        <ENT>Rexall Drug Co., 135 Chesterfield Industrial Blvd., Chesterfield, MO 63017.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 061519</ENT>
                        <ENT>Bacitracin Zinc and Neomycin Sulfate Ointment</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 061520</ENT>
                        <ENT>Bacitracin Zinc and Neomycin Sulfate/Polymyxin B Sulfate Ointment</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 061521</ENT>
                        <ENT>Bacitracin Zinc, Benzocaine, and Neomycin Sulfate/Polymyxin B Sulfate Ointment</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 061528</ENT>
                        <ENT>Penicillin V Potassium Tablets USP, EQ 250 mg base and EQ 500 mg base</ENT>
                        <ENT>American Antibiotics, Inc., 6110 Robinwood Rd., Baltimore, MD 21225.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 061529</ENT>
                        <ENT>Penicillin V Potassium for Oral Solution USP, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 061532</ENT>
                        <ENT>Ampicillin Trihydrate Capsules</ENT>
                        <ENT>Leiner Health Products, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 061601</ENT>
                        <ENT>Ampicillin for Oral Suspension USP, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL</ENT>
                        <ENT>American Antibiotics, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 061602</ENT>
                        <ENT>Ampicillin Capsules USP, EQ 250 mg base and EQ 500 mg base</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 061632</ENT>
                        <ENT>Ampicillin Trihydrate Capsules, 250 mg</ENT>
                        <ENT>Chromalloy Pharmaceuticals, Inc., 5353 Grosvenor Blvd., Los Angeles, CA 90066.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 061674</ENT>
                        <ENT>Penicillin V Potassium Tablets</ENT>
                        <ENT>Leiner Health Products, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 061697</ENT>
                        <ENT>Griseofulvin Capsules</ENT>
                        <ENT>Watson Laboratories, Inc., 311 Bonnie Cir., Corona, CA 92880.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 061699</ENT>
                        <ENT>Bacitracin Powder for Rx Compounding, 5,000,000 units/bottle</ENT>
                        <ENT>Apothekernes Laboratorium A.S., c/o AL Laboratories, Inc., 1 Executive Dr., Fort Lee, NJ 07024.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 061833</ENT>
                        <ENT>Oxytetracycline HCl Capsules, 250 mg</ENT>
                        <ENT>Pliva, c/o Transtrade USA, Ltd., 515 Madison Ave., 4th Floor East, New York, NY 10022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 061847</ENT>
                        <ENT>Bleomycin Sulfate Injection</ENT>
                        <ENT>Takasaki Plant, Nippon Kayaku Co., Ltd., 500 5th Ave., Suite 1726, New York, NY 10110.</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="58678"/>
                        <ENT I="01">ANDA 061857</ENT>
                        <ENT>Penicillamine Powder</ENT>
                        <ENT>Chemiewerk Homberg, c/o Wallace Laboratories, Cranbury, NJ 08512.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 061903</ENT>
                        <ENT>Bacitracin Zinc and Polymyxin B Sulfate Ointment</ENT>
                        <ENT>Ambix Laboratories, Division of Organics Corp. of America.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 062085</ENT>
                        <ENT>Tetracycline HCl Capsules, 250 mg</ENT>
                        <ENT>MM Mast and Co., 4152 Ruple Rd., Cleveland, OH 44121.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 062205</ENT>
                        <ENT>Cefaclor Capsules USP, EQ 250 mg base and EQ 500 mg base</ENT>
                        <ENT>Ceph International Corp. c/o Mova Pharmaceutical Corp., State Rd. #1, Jose Garrido St., Cagus, PR 00725.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 062340</ENT>
                        <ENT>Gentamicin Sulfate Injection</ENT>
                        <ENT>Pharmaceutical Specialist Association, 9852 Cowden St., Philadelphia, PA 19115.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 062467</ENT>
                        <ENT>E-Solve 2 (erythromycin) Lotion, 2%</ENT>
                        <ENT>Syosset Laboratories, Inc., 150 Eileen Way, Syosset, NY 11791.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 062758</ENT>
                        <ENT>Eryzole (erythromycin ethylsuccinate and sulfisoxazole acetyl) Granules, EQ 200 mg base/5 mL; EQ 600 mg base/5 mL</ENT>
                        <ENT>Alra Laboratories, Inc., 3850 Clearview Ct., Gurnee, IL 60031.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 062944</ENT>
                        <ENT>Clindamycin Phosphate Topical Solution USP, EQ 1% base</ENT>
                        <ENT>BOCA Pharmacal, LLC., 3550 North West 126th Ave., Coral Springs, FL 33065.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 070104</ENT>
                        <ENT>Chlorhexidine Gluconate Topical Solution, 4%</ENT>
                        <ENT>Matrix Medical Corp., 1825 South 3730 West, Salt Lake City, UT 84104.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071054</ENT>
                        <ENT>Constilac (lactulose) Solution, 10 g/15 mL</ENT>
                        <ENT>Alra Laboratories, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071057</ENT>
                        <ENT>Ibu-tab 200 (ibuprofen) Tablets, 200 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071058</ENT>
                        <ENT>Ibu-tab (ibuprofen) Tablets, 400 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071059</ENT>
                        <ENT>Ibu-tab (ibuprofen) Tablets, 600 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071104</ENT>
                        <ENT>Leucovorin Calcium Tablets, EQ 15 mg base</ENT>
                        <ENT>Xanodyne Pharmacal, Inc., 7310 Turfway Rd., Suite 490, Florence, KY 41042.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071139</ENT>
                        <ENT>Trazodone HCl Tablets, 50 mg</ENT>
                        <ENT>American Therapeutics, Inc., 89 Carlough Rd., Bohemia, NY 11716.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071140</ENT>
                        <ENT>Trazodone HCl Tablets, 100 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071331</ENT>
                        <ENT>Cholac (lactulose) Solution, 10 g/15 mL</ENT>
                        <ENT>Alra Laboratories, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071362</ENT>
                        <ENT>Meclofenamate Sodium Capsules USP, 50 mg</ENT>
                        <ENT>American Therapeutics, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071363</ENT>
                        <ENT>Meclofenamate Sodium Capsules USP, 100 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071419</ENT>
                        <ENT>Brian Care (chlorhexidine gluconate) Topical Solution, 4%</ENT>
                        <ENT>Soapco, Inc., P.O. Box 5490, Pleasanton, CA 94566.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071429</ENT>
                        <ENT>Clorazepate Dipotassium Capsules, 3.75 mg</ENT>
                        <ENT>American Therapeutics, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071430</ENT>
                        <ENT>Clorazepate Dipotassium Capsules, 7.5 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071431</ENT>
                        <ENT>Clorazepate Dipotassium Capsules, 15 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071569</ENT>
                        <ENT>Danazol Capsules USP, 200 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071787</ENT>
                        <ENT>Gen-Xene (clorazepate dipotassium) Tablets, 3.75 mg</ENT>
                        <ENT>Alra Laboratories, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071788</ENT>
                        <ENT>Gen-Xene (clorazepate dipotassium) Tablets, 7.5 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071789</ENT>
                        <ENT>Gen-Xene (clorazepate dipotassium) Tablets, 15 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071955</ENT>
                        <ENT>Oxazepam Capsules USP, 10 mg</ENT>
                        <ENT>American Therapeutics, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071956</ENT>
                        <ENT>Oxazepam Capsules USP, 15 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071957</ENT>
                        <ENT>Oxazepam Capsules USP, 30 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071962</ENT>
                        <ENT>Leucovorin Calcium Tablets, EQ 10 mg base</ENT>
                        <ENT>Xanodyne Pharmacal, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 071965</ENT>
                        <ENT>Ibu-tab (ibuprofen) Tablets, 800 mg</ENT>
                        <ENT>Alra Laboratories, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 072022</ENT>
                        <ENT>Triamterene and Hydrochlorothiazide Tablets, 75 mg/50 mg</ENT>
                        <ENT>American Therapeutics, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 072129</ENT>
                        <ENT>Maprotiline HCl Tablets USP, 25 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 072130</ENT>
                        <ENT>Maprotiline HCl Tablets USP, 50 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 072131</ENT>
                        <ENT>Maprotiline HCl Tablets USP, 75 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 072190</ENT>
                        <ENT>Metaproterenol Sulfate Inhalation Solution, 5%</ENT>
                        <ENT>Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 072255</ENT>
                        <ENT>Microderm (chlorhexidine gluconate) Topical Solution, 4%</ENT>
                        <ENT>Johnson and Johnson Medical, Inc., 2500 Arbrook Blvd., Arlington, TX 76014.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 072292</ENT>
                        <ENT>Prevacare R (chlorhexidine gluconate) Topical Solution, 0.5%</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 072295</ENT>
                        <ENT>Microderm (chlorhexidine gluconate) Topical Sponge, 4%</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 072307</ENT>
                        <ENT>Fenoprofen Calcium Capsules USP, 200 mg</ENT>
                        <ENT>American Therapeutics, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 072308</ENT>
                        <ENT>Fenoprofen Calcium Capsules USP, 300 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 072309</ENT>
                        <ENT>Fenoprofen Calcium Tablets USP, 600 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 072782</ENT>
                        <ENT>Prazosin HCl Capsules USP, 1 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 072783</ENT>
                        <ENT>Prazosin HCl Capsules USP, 2 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 072784</ENT>
                        <ENT>Prazosin HCl Capsules USP, 5 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 073535</ENT>
                        <ENT>Piroxicam Capsules, 10 mg</ENT>
                        <ENT>Mutual Pharmaceutical Co., Inc., 1100 Orthodox St., Philadelphia, PA 19124.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 074523</ENT>
                        <ENT>Metromidol (metronidazole) Tablets, 250 mg and 500 mg</ENT>
                        <ENT>Laboratorios Applicaciones Farmaceuticas S.A. de CV, c/o Richard Hamer Association, Inc., P.O. Box 16598, Fort Worth, TX 76162.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 074560</ENT>
                        <ENT>Flurbiprofen Tablets USP, 100 mg</ENT>
                        <ENT>Theragen, Inc., 10 Lake Dr., East Windsor, NJ 08520.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 074702</ENT>
                        <ENT>Metaproterenol Sulfate Syrup, 10 mg/5 mL</ENT>
                        <ENT>Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 074881</ENT>
                        <ENT>Iopamidol Injection, 41%, 51%, 61%, and 76%</ENT>
                        <ENT>Cook Imaging Corp., 927 South Curry Pike, P.O. Box 3068, Bloomington, IN 47403.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 075181</ENT>
                        <ENT>Prednisolone Sodium Phosphate Oral Solution, EQ 5 mg base/5 mL</ENT>
                        <ENT>WE Pharmaceuticals, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="58679"/>
                        <ENT I="01">ANDA 075260</ENT>
                        <ENT>Tretinoin Topical Solution, 0.05%</ENT>
                        <ENT>Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 075414</ENT>
                        <ENT>Nifedipine Extended-Release Tablets, 90 mg</ENT>
                        <ENT>Martec USA, LLC, 1800 North Topping Ave., Kansas City, MO 64120.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 075507</ENT>
                        <ENT>Ipratropium Bromide Inhalation Solution, 0.02%</ENT>
                        <ENT>Pharmascience, Inc., 10 Orchard Pl., Tenafly City, NJ 07670.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 075569</ENT>
                        <ENT>Thallous Chloride TL 201 Injection USP, 1 mCi/mL</ENT>
                        <ENT>Trace Life Sciences, Inc., 2101 Shady Oaks, Denton, TX 76205.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 075586</ENT>
                        <ENT>Metaproterenol Sulfate Inhalation Solution, 0.4% and 0.6%</ENT>
                        <ENT>Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 075619</ENT>
                        <ENT>Minoxidil Extra Strength (for Men) Topical Solution, 5%</ENT>
                        <ENT>Avacor Products, LLC, 227 East 56th St., 3rd Floor, New York, NY 10022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 075766</ENT>
                        <ENT>Calcitriol Injection, 1 microgram (mcg)/mL and 2 mcg/mL</ENT>
                        <ENT>Fresenius Medical Care North America, 95 Hayden Ave., Lexington, MA 02421.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 075941</ENT>
                        <ENT>Strontium Chloride SR-89 Injection, 1 mCi/mL</ENT>
                        <ENT>Bio-Nucleonics, Inc., 1600 Market St., Suite 13200, Philadelphia, PA 19103.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 077072</ENT>
                        <ENT>Ipratropium Bromide Inhalation Solution, 0.02%</ENT>
                        <ENT>Landela Pharmaceutical, 776 East Riverside Dr., Suite 150, Eagle, ID 83616.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 077218</ENT>
                        <ENT>ThyroShield (potassium iodide) Oral Solution USP, 65 mg/mL</ENT>
                        <ENT>Arco Pharmaceuticals, LLC, 7605 Maryland Ave., St. Louis, MO 63105.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 077569</ENT>
                        <ENT>Albuterol Sulfate Inhalation Solution, EQ 0.083% base</ENT>
                        <ENT>Landela Pharmaceutical.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 080024</ENT>
                        <ENT>Sulfacel-15 (sulfacetamide sodium) Ophthalmic Solution, 15%</ENT>
                        <ENT>Optopics Laboratories Corp., P.O. Box 210, Fairton, NJ 08320.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 080036</ENT>
                        <ENT>Sosol (sulfisoxazole) Tablets, 500 mg</ENT>
                        <ENT>MK Laboratories, Inc., 424 Grasmere Ave., Fairfield, CT 06430.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 080366</ENT>
                        <ENT>Soxazole (sulfisoxazole) Tablets, 500 mg</ENT>
                        <ENT>Alra Laboratories, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 080380</ENT>
                        <ENT>Bamate (meprobamate) Tablets, 200 mg and 400 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 080483</ENT>
                        <ENT>Hi-cor (hydrocortisone) Cream, 2.5%</ENT>
                        <ENT>C and M Pharmacal, Inc., 1519 East 8 Mile Rd., Hazel Park, MI 48030.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 080492</ENT>
                        <ENT>Reserpine Tablets, 0.1 mg and 0.25 mg</ENT>
                        <ENT>Marshall Pharmacal Corp., 89 Michael St., South Hackensack, NJ 07606.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 080518</ENT>
                        <ENT>Dimenhydrinate Tablets, 50 mg</ENT>
                        <ENT>Alra Laboratories, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 080519</ENT>
                        <ENT>Diphenhydramine HCl Capsules, 25 mg and 50 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 080525</ENT>
                        <ENT>Reserpine Tablets, 0.1 mg and 0.25 mg</ENT>
                        <ENT>MK Laboratories, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 080592</ENT>
                        <ENT>Diphenhydramine HCl Capsules, 50 mg</ENT>
                        <ENT>Valeant Pharmaceuticals International, One Enterprise, Aliso Viejo, CA 92656.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 080660</ENT>
                        <ENT>Ocusulf (sulfacetamide sodium) Ophthalmic Solution, 10% and 30%</ENT>
                        <ENT>Miza Pharmaceuticals USA, Inc., c/o Optopics Laboratories, 40 Main St., P.O. Box 210, Fairton, NJ 08320.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 080714</ENT>
                        <ENT>Diphenhydramine HCl Oral Solution, 12.5 mg/5 mL</ENT>
                        <ENT>Alra Laboratories, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 080715</ENT>
                        <ENT>Dimenhydrinate Oral Solution, 12.5 mg/4 mL</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 080941</ENT>
                        <ENT>Isoniazid Tablets, 100 mg</ENT>
                        <ENT>MK Laboratories, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 080970</ENT>
                        <ENT>Methscopolamine Bromide Tablets, 2.5 mg</ENT>
                        <ENT>Private Formulations, Inc., 460 Plainfield Ave., Edison, NJ 08818.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 083087</ENT>
                        <ENT>Diphenhydramine HCl Capsules, 25 mg and 50 mg</ENT>
                        <ENT>MK Laboratories, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 083088</ENT>
                        <ENT>Diphenhydramine HCl Elixir, 12.5 mg/5 mL</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 083264</ENT>
                        <ENT>Pentobarbital Sodium Capsules, 100 mg</ENT>
                        <ENT>Valeant Pharmaceuticals International.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 083286</ENT>
                        <ENT>Chlorpheniramine Maleate Tablets</ENT>
                        <ENT>Marshall Pharmacal Corp.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 083315</ENT>
                        <ENT>Procaine HCl Injection, 1% and 2%</ENT>
                        <ENT>Elkins Sinn Pharmaceutical Co., c/o ESI Lederle, 2 Esterbrook Ln., Cherry Hill, NJ 08003.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 083320</ENT>
                        <ENT>Acetazolamide Tablets, 250 mg</ENT>
                        <ENT>Alra Laboratories, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 083389</ENT>
                        <ENT>Epinephrine and Lidocaine HCl Injection, 0.01 mg/mL and 1%</ENT>
                        <ENT>Dell Laboratories, Inc., 668 Front St., Teaneck, NJ 07666.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 083390</ENT>
                        <ENT>Epinephrine and Lidocaine HCl Injection, 0.01 mg/mL and 2%</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 083457</ENT>
                        <ENT>Vitamin A Palmitate Capsules, EQ 25,000 units base and EQ 50,000 units base</ENT>
                        <ENT>MK Laboratories, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 083524</ENT>
                        <ENT>Butabarbital Sodium Tablets, 16.2 mg</ENT>
                        <ENT>Marshall Pharmacal Corp.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 083525</ENT>
                        <ENT>Niacin Tablets, 500 mg</ENT>
                        <ENT>MK Laboratories, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 083526</ENT>
                        <ENT>Folic Acid Tablets, 1 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 083658</ENT>
                        <ENT>Promethazine HCl Tablets, 25 mg</ENT>
                        <ENT>Private Formulations, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 083806</ENT>
                        <ENT>Dexamethasone Tablets, 0.75 mg</ENT>
                        <ENT>Phoenix Laboratories, Inc., 175 Lauman Ln., East Hicksville, NY 11801.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 083827</ENT>
                        <ENT>Pramine (imipramine HCl) Tablets, 10 mg, 25 mg, and 50 mg</ENT>
                        <ENT>Alra Laboratories, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 083858</ENT>
                        <ENT>Butabarbital Sodium Tablets, 32.4 mg</ENT>
                        <ENT>Marshall Pharmacal Corp.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 083863</ENT>
                        <ENT>Sulfisoxazole Cream</ENT>
                        <ENT>Holland Rantos Co., Inc., P.O. Box 385, Piscataway, NJ 08854.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 084185</ENT>
                        <ENT>Bethanechol Chloride Tablets, 10 mg</ENT>
                        <ENT>Wendt Laboratories, Inc., 200 West Beaver, P.O. Box 128, Belle Plaine, MN 56011.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 084186</ENT>
                        <ENT>Bethanechol Chloride Tablets, 25 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 084188</ENT>
                        <ENT>Myotonachol (bethanechol chloride) Tablets, 5 mg, 10 mg, and 25 mg</ENT>
                        <ENT>Glenwood, Inc., 83 North Summit St., P.O. Box 518, Tenafly, NJ 07670.</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="58680"/>
                        <ENT I="01">ANDA 084246</ENT>
                        <ENT>Cortisone Acetate Tablets, 25 mg</ENT>
                        <ENT>Everylife, 2021 15th Ave., West Seattle, WA 98119.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 084439</ENT>
                        <ENT>Prednisolone Tablets, 1 mg, 2.5 mg, and 5 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 084440</ENT>
                        <ENT>Prednisone Tablets, 1 mg, 2.5 mg, and 5 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 084494</ENT>
                        <ENT>Hydrochlorothiazide Tablets</ENT>
                        <ENT>West-Ward Pharmaceutical Corp.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 084590</ENT>
                        <ENT>Pentobarbital Sodium Capsules, 100 mg</ENT>
                        <ENT>Anabolic, Inc., 1835 East Cheyenne Rd., Colorado Springs, CO 80905.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 084687</ENT>
                        <ENT>Niacin Tablets, 500 mg</ENT>
                        <ENT>Zzeon Pharmaceuticals, Ltd., Jamboree at Kevin, Irvine, CA 92705.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 084714</ENT>
                        <ENT>Hydro-Reserp (hydrochlorothiazide and reserpine) Tablets, 50 mg/0.125 mg</ENT>
                        <ENT>ABC Holding Corp., P.O. Box 307, 70945 Van Dyke Ave., Romeo, MI 48065.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 084729</ENT>
                        <ENT>Lidocaton (epinephrine and lidocaine HCl) Injection, 0.01 mg/mL and 2%</ENT>
                        <ENT>Pharmaton, Ltd., c/o Bass Ullmna and Lustigman, 747 3rd Ave., New York, NY 10017.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 084872</ENT>
                        <ENT>Meclizine HCl Tablets, 25 mg</ENT>
                        <ENT>CM Bundy Co., 2055 Reading Rd., Cincinnati, OH 45205.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 084902</ENT>
                        <ENT>Promethacon (promethazine HCl) Suppository, 50 mg</ENT>
                        <ENT>Polymedica Industries, Inc., 2 Constitution Way, Woburn, MA 01801.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 084931</ENT>
                        <ENT>Methamphetamine HCl Tablets, 5 mg and 10 mg</ENT>
                        <ENT>Rexar Pharmacal, 396 Rockaway Ave., Valley Stream, NY 11581.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 084933</ENT>
                        <ENT>Diethylstilbestrol Tablets, 1 mg</ENT>
                        <ENT>West-Ward Pharmaceutical Corp.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 084977</ENT>
                        <ENT>Halothane Inhalation, 99.99%</ENT>
                        <ENT>BH Chemicals, Inc., 500 5th Ave., New York, NY 10036.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085009</ENT>
                        <ENT>Lygen (chlordiazepoxide HCl) Capsules, 10 mg</ENT>
                        <ENT>Alra Laboratories, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085039</ENT>
                        <ENT>Folic Acid Tablets USP, 1 mg</ENT>
                        <ENT>Wendt Laboratories, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085040</ENT>
                        <ENT>Isoniazid Tablets USP, 100 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085041</ENT>
                        <ENT>Meclizine HCl Tablets, 25 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085042</ENT>
                        <ENT>Methocarbamol Tablets USP, 500 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085044</ENT>
                        <ENT>Reserpine Tablets USP, 0.25 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085075</ENT>
                        <ENT>
                            Aerolate III (theophylline) Extended-Release Capsules, 65 mg
                            <LI>Aerolate JR (theophylline) Extended-Release Capsules, 130 mg</LI>
                            <LI>Aerolate SR (theophylline) Extended-Release Capsules, 260 mg</LI>
                        </ENT>
                        <ENT>Fleming and Co. Pharmaceuticals, Inc., 1600 Fenton Park Dr., Fenton, MO 63026.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085107</ENT>
                        <ENT>Lygen (chlordiazepoxide HCl) Capsules, 5 mg</ENT>
                        <ENT>Alra Laboratories, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085108</ENT>
                        <ENT>Lygen (chlordiazepoxide HCl) Capsules, 25 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085125</ENT>
                        <ENT>Methyltestosterone Sublingual Tablets, 10 mg</ENT>
                        <ENT>Tablicaps, Inc., P.O. Box 5555, Franklinville, NJ 08322.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085235</ENT>
                        <ENT>Chlordiazepoxide HCl Capsules</ENT>
                        <ENT>Abbott Laboratories, Pharmaceutical Products Division, 100 Abbott Park Rd., Abbott Park, IL 60064.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085236</ENT>
                        <ENT>Chlordiazepoxide HCl Capsules</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085252</ENT>
                        <ENT>Meclizine HCl Tablets, 25 mg</ENT>
                        <ENT>ABC Holding Corp.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085253</ENT>
                        <ENT>Meclizine HCl Tablets, 12.5 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085282</ENT>
                        <ENT>Hydrocortisone Lotion, 0.5% and 1%</ENT>
                        <ENT>Mericon Industries, Inc., 8819 North Pioneer Rd., Peoria, IL 61615.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085383</ENT>
                        <ENT>Butabarbital Sodium Elixir, 30 mg/5 mL</ENT>
                        <ENT>Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085411</ENT>
                        <ENT>Phentermine HCl Capsules, 30 mg</ENT>
                        <ENT>ABC Holding Corp.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085511</ENT>
                        <ENT>Cam-Metrazine (phendimetrazine tartrate) Tablets, 35 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085512</ENT>
                        <ENT>Phenazine-35 (phendimetrazine tartrate) Tablets, 35 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085550</ENT>
                        <ENT>Butabarbital Sodium Tablets, 30 mg</ENT>
                        <ENT>CM Bundy Co.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085569</ENT>
                        <ENT>Chlorothiazide Tablets, 250 mg</ENT>
                        <ENT>ABC Holding Corp.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085587</ENT>
                        <ENT>Meclizine HCl Chewable Tablets</ENT>
                        <ENT>Camall Co., Inc., 60950 Van Dyke Ave., P.O. Box 218, Washington, MI 48094.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085672</ENT>
                        <ENT>Hydrochlorothiazide Tablets, 50 mg</ENT>
                        <ENT>ABC Holding Corp.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085756</ENT>
                        <ENT>Cam-Metrazine (phendimetrazine tartrate) Tablets, 35 mg</ENT>
                        <ENT>Camall Co., Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085766</ENT>
                        <ENT>Atropine Sulfate and Diphenoxylate HCl Tablets, 0.025 mg/2.5 mg</ENT>
                        <ENT>Private Formulations, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085888</ENT>
                        <ENT>Brompheniramine Maleate Tablets</ENT>
                        <ENT>Leiner Health Products, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085891</ENT>
                        <ENT>Meclizine HCl Tablets, 25 mg</ENT>
                        <ENT>Anabolic, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 085895</ENT>
                        <ENT>Secobarbital Sodium Capsules, 100 mg</ENT>
                        <ENT>Everylife.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086008</ENT>
                        <ENT>Hydrocortisone and Urea Cream, 1%/10%</ENT>
                        <ENT>Bioglan Laboratories, Ltd., 450 Hilltop Rd., Riegelsville, PA 18077.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086077</ENT>
                        <ENT>Nitrofurazone Ointment, 0.2%</ENT>
                        <ENT>Ambix Laboratories, Division of Organics Corp. of America.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086079</ENT>
                        <ENT>Hydrocortisone Ointment, 1%</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086080</ENT>
                        <ENT>Hydrocortisone Cream, 1%</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086141</ENT>
                        <ENT>Tolbutamide Tablets, 500 mg</ENT>
                        <ENT>Alra Laboratories, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086260</ENT>
                        <ENT>Ona-Mast (phentermine HCl) Tablets, 8 mg</ENT>
                        <ENT>MM Mast and Co.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086271</ENT>
                        <ENT>Hydrocortisone Cream, 2.5%</ENT>
                        <ENT>Ambix Laboratories, Division of Organics Corp. of America.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086272</ENT>
                        <ENT>Hydrocortisone Ointment, 2.5%</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086498</ENT>
                        <ENT>Amitriptyline HCl Tablets, 10 mg</ENT>
                        <ENT>Alra Laboratories, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086499</ENT>
                        <ENT>Amitriptyline HCl Tablets, 50 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086500</ENT>
                        <ENT>Amitriptyline HCl Tablets, 150 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086501</ENT>
                        <ENT>Amitriptyline HCl Tablets, 100 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086502</ENT>
                        <ENT>Amitriptyline HCl Tablets, 25 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086503</ENT>
                        <ENT>Amitriptyline HCl Tablets, 75 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="58681"/>
                        <ENT I="01">ANDA 086511</ENT>
                        <ENT>Ona-Mast (phentermine HCl) Capsules, 30 mg</ENT>
                        <ENT>MM Mast and Co.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086516</ENT>
                        <ENT>Ona-Mast (phentermine HCl) Capsules, 30 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086550</ENT>
                        <ENT>X-Trozine (phendimetrazine tartrate) Tablets, 35 mg</ENT>
                        <ENT>Shire Richwood, Inc., 7900 Tanners Gate Dr., Suite 200, Florence, KY 41042.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086551</ENT>
                        <ENT>X-Trozine (phendimetrazine tartrate) Tablets, 35 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086552</ENT>
                        <ENT>X-Trozine (phendimetrazine tartrate) Tablets, 35 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086553</ENT>
                        <ENT>X-Trozine (phendimetrazine tartrate) Tablets, 35 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086554</ENT>
                        <ENT>X-Trozine (phendimetrazine tartrate) Tablets, 35 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086735</ENT>
                        <ENT>Phentermine HCl Capsules, 15 mg</ENT>
                        <ENT>Camall Co., Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086748</ENT>
                        <ENT>Theophylline Elixir, 80 mg/15 mL</ENT>
                        <ENT>Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 086766</ENT>
                        <ENT>Nitrofurazone Ointment, 0.2%</ENT>
                        <ENT>Wendt Laboratories, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 087081</ENT>
                        <ENT>Nitrofurazone Topical Solution, 0.2%</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 087226</ENT>
                        <ENT>Phentermine HCl Capsules, 30 mg</ENT>
                        <ENT>Camall Co., Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 087371</ENT>
                        <ENT>X-Trozine L.A. (phendimetrazine tartrate) Extended-Release Capsules, 105 mg</ENT>
                        <ENT>Shire Richwood, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 087392</ENT>
                        <ENT>Aminophylline Injection, 25 mg/mL</ENT>
                        <ENT>Pharma Serve, Inc., Subsidiary of Torigian Laboratories, 218-20 98th Ave., Queens Village, NY 11429.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 087394</ENT>
                        <ENT>X-Trozine (phendimetrazine tartrate) Capsules, 35 mg</ENT>
                        <ENT>Shire Richwood, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 087442</ENT>
                        <ENT>Neosar (cyclophosphamide) for Injection, 100 mg/vial, 200 mg/vial, 500 mg/vial, 1 g/vial, and 2 g/vial</ENT>
                        <ENT>Bedford Laboratories, Division of Ben Venue Laboratories, Inc., 300 Northfield Rd., Bedford, OH 44146.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 087487</ENT>
                        <ENT>Melfiat-105 (phendimetrazine tartrate) Extended-Release Capsules, 105 mg</ENT>
                        <ENT>Numark Laboratories, Inc., 75 Mayfield Ave., Edison, NJ 08837.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 087636</ENT>
                        <ENT>Tropicamide Ophthalmic Solution, 0.5%</ENT>
                        <ENT>Miza Pharmaceuticals USA, Inc., c/o Optopics Laboratories.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 087637</ENT>
                        <ENT>Tropicamide Ophthalmic Solution, 1%</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 087681</ENT>
                        <ENT>Paracaine (proparacaine HCl) Ophthalmic Solution, 0.5%</ENT>
                        <ENT>Optopics Laboratories Corp.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 087764</ENT>
                        <ENT>Oby-Trim (phentermine HCl) Capsules, 30 mg</ENT>
                        <ENT>Shire Richwood, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 087932</ENT>
                        <ENT>Triamcinolone Acetonide Cream, 0.025%</ENT>
                        <ENT>Ambix Laboratories, Division of Organics Corp. of America.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 088786</ENT>
                        <ENT>Sodium Polystyrene Sulfonate USP Powder, 453.6 g/bottle</ENT>
                        <ENT>Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 088897</ENT>
                        <ENT>Promethazine VC Plain (phenylephrine HCl and promethazine HCl) Syrup, 5 mg/5 mL and 6.25 mg/5 mL</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 089141</ENT>
                        <ENT>Aerolate (theophylline) Oral Solution, 150 mg/15 mL</ENT>
                        <ENT>Fleming and Co. Pharmaceuticals, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 089417</ENT>
                        <ENT>Methocarbamol Tablets USP, 500 mg</ENT>
                        <ENT>American Therapeutics, Inc.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 089418</ENT>
                        <ENT>Methocarbamol Tablets USP, 750 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 089478</ENT>
                        <ENT>Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/15 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 089479</ENT>
                        <ENT>Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/30 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 089480</ENT>
                        <ENT>Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/60 mg</ENT>
                        <ENT>  Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 089514</ENT>
                        <ENT>Trihexyphenidyl HCl Elixir, 2 mg/5 mL</ENT>
                        <ENT>Pharmaceutical Ventures, Ltd., P.O. Box D3700, Pomona, NY 10970.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 089726</ENT>
                        <ENT>Prednisone Oral Solution, 5 mg/5 mL</ENT>
                        <ENT>Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>FDA finds that the holders of the ANDAs listed in table 1 have repeatedly failed to submit reports required by §§ 314.81 and 314.98. In addition, under § 314.200, FDA finds that the holders of the ANDAs have waived any contentions concerning the legal status of the drug products. Therefore, under these findings, approval of the ANDAs listed in table 1 and all amendments and supplements thereto, is hereby withdrawn, effective October 22, 2021.</P>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>Lauren K. Roth,</NAME>
                    <TITLE>Associate Commissioner for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23075 Filed 10-21-21; 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>National Institutes of Health</SUBAGY>
                <SUBJECT>Prospective Grant of Exclusive Patent Commercialization License: CD28H Domain-Containing Chimeric Antigen Receptors and Methods of Use</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Institutes of Health, Health and Human Services (HHS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Ankarys Therapeutics Inc., located at 110 Cumberland Street, Suite 520, M5R 3V5, Toronto, Ontario, Canada, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Only written comments and/or applications for a license which are received by the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases on or before November 8, 2021 will be considered.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Requests for copies of the patent applications, inquiries, and comments relating to the contemplated exclusive patent license should be directed to: Dawn Taylor-Mulneix, Technology Transfer and Patent Specialist, Technology Transfer and 
                        <PRTPAGE P="58682"/>
                        Intellectual Property Office, National Institute of Allergy and Infectious Diseases, National Institutes of Health; phone number 301-767-5189, or 
                        <E T="03">dawn.taylor-mulneix@nih.gov.</E>
                    </P>
                </ADD>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The following represents the intellectual property to be licensed under the prospective agreement: PCT Patent Application Number PCT/US2020/024985, filed March 26, 2020, entitled “CD28H Domain-Containing Chimeric Antigen Receptors and Methods of Use” (HHS Reference No. E-097-2020-00-PCT), and U.S. and foreign patent applications claiming priority to the aforementioned application.</P>
                <P>All rights in these inventions have been assigned to the Government of the United States of America.</P>
                <P>The prospective exclusive patent commercialization license territory may be worldwide, and the field of use may be limited to: “Use of natural killer cell immunotherapies for the treatment of multiple myeloma, non-Hodgkin lymphoma, and pancreatic cancer”.</P>
                <P>Engineered chimeric antigen receptors (CARs) that are expressed in cytotoxic T cells and natural killer (NK) cells have been used to specifically target tumor cells. However, CAR-T and CAR-NK cells are still subject to down regulation by their inhibitory receptors after injection into patients.</P>
                <P>
                    Scientists at NIAID have developed CAR constructs that overcome inhibition of NK cells by receptors for human major histocompatibility complex molecules HLA-E and HLA-C, based on in vitro studies. The CAR contains an antigen binding domain of receptor CD28 homolog (CD28H), a CD28H transmembrane domain (TM), a CD28H signaling domain, and other intracellular signaling domains, such as 2B4 (CD244) and CD3 zeta chain (CD3zeta). A variant of this CAR, in which the antigen binding domain of CD28H is replaced by a single-chain antibody variable region (scFv) that binds to CD19, rendered NK cells resistant to inhibition by HLA-E and HLA-C on CD19+ tumor cells. An abstract for this invention was published in the 
                    <E T="04">Federal Register</E>
                     on April 22, 2020.
                </P>
                <P>This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive patent commercialization license will be royalty bearing, and may be granted unless within fifteen (15) days from the date of this published notice, the National Institute of Allergy and Infectious Diseases receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.</P>
                <P>
                    Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive patent commercialization license. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available. License applications submitted in response to this Notice will be presumed to contain business confidential information, and any release of information in these license applications will be made only as required and upon a request under the 
                    <E T="03">Freedom of Information Act,</E>
                     5 U.S.C. 552.
                </P>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>Surekha Vathyam,</NAME>
                    <TITLE>Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23092 Filed 10-21-21; 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>Center for Scientific Review; Amended Notice of Meeting</SUBJECT>
                <P>
                    Notice is hereby given of a change in the meeting of the Cellular and Molecular Biology of Neurodegeneration Study Section, October 28, 2021, 10:00 a.m. to October 29, 2021, 06:00 p.m., National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the 
                    <E T="04">Federal Register</E>
                     on September 24, 2021, FR Doc 2021-20784 86 FR 53084.
                </P>
                <P>This meeting is being amended to change the Contact Person from Christine Jean DiDonato to Laurent Taupenot, Ph.D., Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (301) 435-1203. The meeting is closed to the public.</P>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>David W. Freeman,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23082 Filed 10-21-21; 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>Center for Scientific Review; Notice of Closed Meetings</SUBJECT>
                <P>Pursuant to section 10(d) 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 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>
                         Center for Scientific Review Special Emphasis Panel; Fellowships: Physiology and Pathobiology of Cardiovascular and Respiratory Systems.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         November 16-17, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 9:00 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>
                         Kimm Hamann, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4118A, MSC 7814, Bethesda, MD 20892, 301-435-5575, 
                        <E T="03">hamannkj@csr.nih.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Center for Scientific Review Special Emphasis Panel; Fellowships: Population Sciences and Epidemiology.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         November 17-18, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 6:30 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>
                         Ananya Paria, DHSC, MPH, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1007H, Bethesda, MD 20892, (301) 827-6513, 
                        <E T="03">pariaa@mail.nih.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Center for Scientific Review Special Emphasis Panel; Infectious Disease and Reproductive Health.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         November 17-18, 2021.
                    </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>
                         Lisa Steele, Ph.D.,  Scientific Review Officer, PSE IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3139, 
                        <PRTPAGE P="58683"/>
                        MSC 7770, Bethesda, MD 20892, 301-594-6594, 
                        <E T="03">steeleln@csr.nih.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Center for Scientific Review Special Emphasis Panel; Member Conflict: Glioma, Multiple Sclerosis, and Neuroinflammation.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         November 17, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.m. to 5:00 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>
                         Samuel C. Edwards, Ph.D., Chief, BDCN IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5210, MSC 7846, Bethesda, MD 20892, (301) 435-1246, 
                        <E T="03">edwardss@csr.nih.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Center for Scientific Review Special Emphasis Panel; PAR Panel: Building Interdisciplinary Research Careers in Women's Health.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         November 18, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         11:00 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>
                         Kate Fothergill, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3142, MSC 7770, Bethesda, MD 20892, (301) 435-2309, 
                        <E T="03">fothergillke@mail.nih.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Center for Scientific Review Special Emphasis Panel; Member Conflict: Topics in Biochemistry and Biophysics.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         November 23, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 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, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         James W. Mack, Ph.D.,  Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4154, MSC 7806, Bethesda, MD 20892, (301) 435-2037, 
                        <E T="03">mackj2@csr.nih.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Center for Scientific Review Special Emphasis Panel; Member Conflict: Immunology.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         November 30, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:30 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, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Kenneth A. Roebuck, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5214, MSC 7852, Bethesda, MD 20892, (301) 435-1166, 
                        <E T="03">roebuckk@csr.nih.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Center for Scientific Review Special Emphasis Panel; Member Conflict: Perceptual, Visual, Motor, and Cognitive Processes.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         November 30, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.m. to 5:00 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>
                         Joseph G. Rudolph, Ph.D., Chief and Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5186, MSC 7844,  Bethesda, MD 20892, 301-408-9098, 
                        <E T="03">josephru@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: October 19, 2021.</DATED>
                    <NAME>David W. Freeman,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23090 Filed 10-21-21; 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 Heart, Lung, and Blood Institute; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 10(d) 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>
                         Heart, Lung, and Blood Initial Review Group; Heart, Lung, and Blood Program Project Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         December 3, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.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, 6705 Rockledge Drive, Bethesda, MD 20817, (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Melissa H. Nagelin, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, National Institutes of Health, 6705 Rockledge Drive, Room 208-R, Bethesda, MD 20892, (301) 827-7951, 
                        <E T="03">nagelinmh2@nhlbi.nih.gov</E>
                        .
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) </FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>David W. Freeman,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy. </TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23089 Filed 10-21-21; 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 Heart, Lung, and Blood Institute; Notice of Closed Meetings</SUBJECT>
                <P>Pursuant to section 10(d) 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 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 Heart, Lung, and Blood Institute Special Emphasis Panel; NHLBI Conference Grants—R13.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         December 2, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         1:30 p.m. to 5:00 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, 6705 Rockledge Drive, Bethesda, MD 20817 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Kristen Page, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, National Institutes of Health, 6705 Rockledge Drive, Room 209-B, Bethesda, MD 20892, (301) 827-7953, 
                        <E T="03">kristen.page@nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Heart, Lung, and Blood Institute Special Emphasis Panel; Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) Multisite Resource and Coordinating Center (U24).
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         December 3, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.m. to 5:00 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, 6705 Rockledge Drive, Bethesda, MD 20817 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Susan Wohler Sunnarborg, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National, Heart, Lung, and Blood Institute, National Institutes of Health, 6705 Rockledge Drive, Room 208-Z, Bethesda, MD 20892, (301) 827-7987, 
                        <E T="03">susan.sunnarborg@nih.gov.</E>
                    </P>
                    <PRTPAGE P="58684"/>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Heart, Lung, and Blood Institute Special Emphasis Panel; Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) Multisite Clinical Centers (UG3-UH3).
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         December 6-7, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.m. to 5:00 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, 6705 Rockledge Drive, Bethesda, MD 20817 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Susan Wohler Sunnarborg, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National, Heart, Lung, and Blood Institute, National Institutes of Health, 6705 Rockledge Drive, Room 208-Z, Bethesda, MD 20892, (301) 827-7987, 
                        <E T="03">susan.sunnarborg@nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Heart, Lung, and Blood Institute Special Emphasis Panel; Catalyze Product Definition.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         December 7, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.m. to 5:00 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, 6705 Rockledge Drive, Bethesda, MD 20817 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Kristin Goltry, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, National Institutes of Health, 6705 Rockledge Drive, Room 209-B, Bethesda, MD 20892, (301) 435-0297, 
                        <E T="03">goltrykl@mail.nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Heart, Lung, and Blood Institute Special Emphasis Panel; Catalyze Enabling Technologies.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         December 10, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.m. to 5:00 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, 6705 Rockledge Drive, Bethesda, MD 20817 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Kristin Goltry, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, National Institutes of Health, 6705 Rockledge Drive, Room 209-B, Bethesda, MD 20892, (301) 435-0297, 
                        <E T="03">goltrykl@mail.nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Heart, Lung, and Blood Institute Special Emphasis Panel; NHLBI Institutional Training Grants.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         December 16, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         12:30 p.m. to 4:30 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, 6705 Rockledge Drive, Bethesda, MD 20817 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Giuseppe Pintucci, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, National Institutes of Health, 6705 Rockledge Drive, Room 205-H, Bethesda, MD 20892, (301) 827-7969, 
                        <E T="03">Pintuccig@nhlbi.nih.gov.</E>
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) </FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>David W. Freeman,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23091 Filed 10-21-21; 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 Eye Institute; Notice of Closed Meetings</SUBJECT>
                <P>Pursuant to section 10(d) 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 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 Eye Institute Special Emphasis Panel; NEI Pathway to Independence (K99) Grant Review.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         December 1, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.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 Eye Institute, National Institutes of Health, 6700B Rockledge Drive, Suite 3400, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Jennifer C. Schiltz, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, National Eye Institute, National Institutes of Health, 6700B Rockledge Drive, Suite 3400, Bethesda, MD 20892, 240-276-5864, 
                        <E T="03">jennifer.schiltz@nih.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Eye Institute Special Emphasis Panel; NEI Institutional Training Grants II.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         December 8, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.m. to 2:30 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Eye Institute, National Institutes of Health, 6700B Rockledge Drive, Suite 3400, Bethesda, MD 20892  (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Ashley Fortress, Ph.D., Designated Federal Official, Division of Extramural Activities, National Eye Institute, National Institutes of Health, 6700B Rockledge Drive, Suite 3400, Bethesda, MD 20892,  (301) 451-2020, 
                        <E T="03">ashley.fortress@nih.gov</E>
                        .
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.867, Vision Research, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>Victoria E. Townsend, </NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23045 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <SUBAGY>Coast Guard</SUBAGY>
                <DEPDOC>[Docket No. USCG-2019-0862]</DEPDOC>
                <SUBJECT>Port Access Route Study: Approaches to the Chesapeake Bay, Virginia</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Coast Guard, DHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Coast Guard announces the completion of the Port Access Route Study for the Approaches to the Chesapeake Bay, Virginia. The study was conducted to determine whether to recommend changes to enhance navigational safety by examining existing shipping routes and waterway uses as offshore energy development matures and to evaluate the need for establishing or changing existing vessel routing measures. This notice summarizes the study's recommendation.</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For information about this document call or email Matthew Creelman, Marine Planner at Fifth Coast Guard District, telephone (757) 398-6225, email, 
                        <E T="03">Matthew.K.Creelman2@uscg.mil.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Table of Abbreviations</HD>
                <EXTRACT>
                    <FP SOURCE="FP-1">BOEM—Bureau of Ocean Energy Management, U.S. Department of the Interior</FP>
                    <FP SOURCE="FP-1">DELMARVA—Delaware, Maryland, Virginia peninsula (Eastern Shore)</FP>
                    <FP SOURCE="FP-1">FR—Federal Register</FP>
                    <FP SOURCE="FP-1">NEPA—National Environmental Policy Act</FP>
                    <FP SOURCE="FP-1">PARS—Port Access Route Study</FP>
                    <FP SOURCE="FP-1">TSS—Traffic Separation Scheme</FP>
                    <FP SOURCE="FP-1">USCG—United States Coast Guard, Department of Homeland Security</FP>
                </EXTRACT>
                <HD SOURCE="HD1">II. Background and Purpose</HD>
                <P>
                    We conducted this Port Access Route Study (PARS) following a Notice of Study, published in the 
                    <E T="04">Federal Register</E>
                     on November 27, 2019 (84 FR 65398). There was a 60-day public comment period, as well as other outreach efforts identified in Section C of the study. During the comment period USCG received 11 comments in response to the notice.
                    <PRTPAGE P="58685"/>
                </P>
                <P>
                    On June 16, 2021, we published a Notice of Availability of the draft study in the 
                    <E T="04">Federal Register</E>
                     (86 FR 32052) with a 30-day public comment period with a request for public comment.
                </P>
                <P>During the 30-day public comment period, the USCG received eleven comments in response to our draft study, as well as other outreach identified in Section G of the study.</P>
                <P>
                    All comments and supporting documents are available in the public docket and can be viewed at 
                    <E T="03">https://www.regulations.gov.</E>
                     To view documents, in the “Search” box insert “USCG-2019-0862” and click “Search.” Then select “Supporting &amp; Related Material” in the Document Type column.
                </P>
                <P>Comments have been addressed and summarized in section III.</P>
                <P>The goal of the study is to enhance navigational safety in the study area by examining existing shipping routes and waterway uses. We have undertaken measures to (1) determine what, if any, navigational safety concerns exist with vessel transits in the study area; (2) determine whether to recommend changes to enhance navigational safety by examining existing shipping routes and all other waterway uses; and (3) reconcile any other proposed changes with other reasonable waterway uses.</P>
                <HD SOURCE="HD1">III. Study Recommendations</HD>
                <P>The recommendations of this PARS are based on the data analysis for historical vessel traffic patterns, comments received to the docket, public outreach, and consultation with other government agencies and stakeholders. Recommendations in the draft study include:</P>
                <P>1. An expansion of the precautionary area between the two Traffic Separation Schemes to preserve a naturally occurring deep draft slough for future increases in vessel size.</P>
                <P>2. Modifications to shipping safety fairways as proposed in the Atlantic Coast Shipping Safety Fairways rulemaking, to include:</P>
                <P>a. Re-orienting the “Chesapeake Bay to Delaware Bay” connector fairway to allow space for an offshore anchorage in the approach to the Delaware Bay.</P>
                <P>b. Re-orienting the “Cape Charles to Montauk Point” fairway to route closer to the DELMARVA peninsula.</P>
                <P>c. Add one connector fairway from the offshore “St. Lucie to New York” fairway and the Chesapeake Bay TSS, south of the Commercial Virginia Offshore Wind project area, to facilitate safe transit of commercial international vessels around future offshore energy installations.</P>
                <P>The final study considered several comments from port and industry stakeholders regarding larger vessels calling on the Port of Virginia in the future, suggesting an additional fairway connector from the Atlantic Coast PARS would be required. These comments were well supported and resulted in changes to the final recommendations.</P>
                <HD SOURCE="HD1">IV. Summary of Changes</HD>
                <P>Section E was modified to address comments on fishing activity within the study area and now contains calculations for recommended safe transit widths based on fishing vessel transit data. Section F changes resulted from public comments requesting addition of a connector fairway north of the Commercial Virginia Offshore Wind lease area. The comments supported the need to preserve a deep draft route to support and promote navigation safety of larger vessels expected to call more frequently on the Port of Virginia in the future. All changes to the final study are indicated by italicized type.</P>
                <HD SOURCE="HD1">V. Future Actions</HD>
                <P>The USCG will continue to serve as a NEPA cooperating agency to BOEM's environmental review of any proposed project. In that role, the USCG will evaluate the navigational safety risks of each proposal on a case-by-case basis.</P>
                <P>The final study will be submitted to the Office of Navigation Systems (CG-NAV-2) for consideration and possible inclusion as part of a future Notice of Proposed Rulemaking for Shipping Safety Fairways along the Atlantic Coast.</P>
                <P>
                    The final study is available for viewing and download from the 
                    <E T="04">Federal Register</E>
                     docket at 
                    <E T="03">http://www.regulations.gov</E>
                     or the USCG Navigation Center website at 
                    <E T="03">https://www.navcen.uscg.gov/?pageName=PARSReports.</E>
                </P>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>Richard E. Batson,</NAME>
                    <TITLE>Captain, U.S. Coast Guard, Acting Commander, Fifth Coast Guard District.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23103 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9110-04-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Indian Affairs</SUBAGY>
                <DEPDOC>[222A2100DD/AAKC001030/A0A501010.999900253G]</DEPDOC>
                <SUBJECT>Indian Gaming; Approval of Tribal-State Class III Gaming Compact in the State of Washington</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Indian Affairs, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice publishes the approval of the Seventh Amendment to the Tribal-State Compact (Amendment) for Class III Gaming between the Swinomish Indian Tribal Community (Tribe) and the State of Washington (State).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The Amendment takes effect on October 22, 2021.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Deputy Assistant Secretary—Policy and Economic Development, Washington, DC 20240, 
                        <E T="03">paula.hart@bia.gov,</E>
                         (202) 219-4066.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Under section 11 of the Indian Gaming Regulatory Act (IGRA), Public Law 100-497, 25 U.S.C. 2701 
                    <E T="03">et seq.,</E>
                     the Secretary of the Interior shall publish in the 
                    <E T="04">Federal Register</E>
                     notice of approved Tribal-State compacts for the purpose of engaging in Class III gaming activities on Indian lands. As required by 25 CFR 293.4, all compacts and amendments are subject to review and approval by the Secretary. The Amendment authorizes the Tribe to engage in sports wagering at the Tribe's class III gaming facilities, updates the Compact to reflect this change in various sections, and incorporates Appendix S, Sports Wagering. The Amendment is approved.
                </P>
                <SIG>
                    <NAME>Bryan Newland,</NAME>
                    <TITLE>Assistant Secretary—Indian Affairs.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23064 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4337-15-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Land Management</SUBAGY>
                <DEPDOC>[20X.LLID933000.L14400000.ET0000.241A00]</DEPDOC>
                <SUBJECT>Notice of Application for Withdrawal Extension and Opportunity for Public Meeting, Lemhi Pass National Historic Landmark, Idaho and Montana [IDI-33690/MTM-90527]</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Land Management, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The United States Forest Service (USFS) has filed an application with the Bureau of Land Management (BLM) requesting that the Secretary of the Interior extend the duration of Public Land Order (PLO) No. 7549 for an additional 20-year term. PLO No. 7549 withdrew 1,328.84 acres of National Forest System land from location and entry under the United States mining laws to protect the Lemhi 
                        <PRTPAGE P="58686"/>
                        Pass National Historic Landmark. The withdrawal created by PLO No. 7549 will expire on December 26, 2022, unless it is extended. The land will remain open to the general land laws and leasing under the mineral leasing laws. This notice also gives an opportunity for the public to comment and to request a public meeting on the withdrawal extension application.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments and public meeting requests must be received by January 20, 2022.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Comments and meeting requests should be sent to the Idaho State Director, BLM, 1387 S Vinnell Way, Boise, Idaho 83709.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>John Sullivan, BLM Idaho State Office, at 208-373-3863 or Hailey Conroy, Lands, USFS Intermountain Regional Office, at 801-625-5802. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact either of the above individuals. The FRS is available 24 hours a day, 7 days a week. You will receive a reply during normal business hours.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The USFS has filed an application requesting that the Secretary of the Interior extend the withdrawal created by PLO No. 7549 for an additional 20-year term, subject to valid existing rights. PLO No. 7549 (67 FR 249 (2002)), hereby incorporated by reference, withdrew 1,328.84 acres of National Forest System land in the Salmon-Challis National Forest, Lemhi County, Idaho, and Beaverhead County, Montana, from mining for a period of 20 years to preserve the unique resources of Lemhi Pass National Historic Landmark. The land has been and will remain open to such forms of disposition as may by law be made of National Forest System land and to mineral leasing. An additional 176.45 acres would become subject to the terms and conditions of this withdrawal upon acquisition of the mineral estate by the United States. The purpose of the requested withdrawal extension is to continue to protect the Lemhi Pass National Historic Landmark and to preserve the historic, recreational, and cultural heritage which this site represents.</P>
                <P>The use of a right-of-way, interagency agreement, or cooperative agreement would not adequately protect the land from nondiscretionary uses that could result in a permanent loss of significant values and capital investments.</P>
                <P>The area proposed for withdrawal extension is a significant national historic area, established as a National Historic Landmark. There are no alternative sites.</P>
                <P>The USFS would not need to acquire water rights to fulfill the purpose of the requested withdrawal extension.</P>
                <P>
                    For a period until January 20, 2022, all persons who wish to submit comments, suggestions, or objections in connection with the withdrawal extension application may present their views in writing to the BLM State Director at the 
                    <E T="02">ADDRESSES</E>
                     section indicated above.
                </P>
                <P>Comments, including names and street addresses of respondents, will be available for public review during regular business hours. 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 may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.</P>
                <P>
                    Notice is hereby given that an opportunity for a public meeting is afforded in connection with the withdrawal extension application. All interested persons who desire a public meeting on the withdrawal extension application must submit a written request to the BLM State Director at the 
                    <E T="02">ADDRESSES</E>
                     section indicated above by January 20, 2022. Upon determination by the authorized officer that a public meeting will be held, a notice of the time and place will be published in the 
                    <E T="04">Federal Register</E>
                     and a newspaper having a general circulation in the vicinity of the land at least 30 days before the scheduled date of the meeting.
                </P>
                <P>The application will be processed in accordance with the regulations set forth in 43 CFR 2310.4.</P>
                <SIG>
                    <NAME>Peter J. Ditton,</NAME>
                    <TITLE>Acting State Director.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23076 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3411-15-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Land Management</SUBAGY>
                <AGENCY TYPE="O">DEPARTMENT OF AGRICULTURE</AGENCY>
                <SUBAGY>Forest Service</SUBAGY>
                <DEPDOC>[212.LLIDI00000.L1330000.EO0000.241A]</DEPDOC>
                <SUBJECT>Notice of Availability of Draft Environmental Impact Statement for the Proposed Husky 1 North Dry Ridge Phosphate Mine, Caribou County, Idaho</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P> Bureau of Land Management, Interior; and United States Forest Service, Agriculture.</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 (NEPA), as amended, the Bureau of Land Management (BLM) and the Forest Service (USFS) Caribou-Targhee National Forest (CTNF) have prepared a Draft Environmental Impact Statement (DEIS) for the proposed Husky 1 North Dry Ridge Phosphate Mine, and by this Notice is announcing the opening of the public comment period.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        To ensure consideration, the agencies must receive written comments on the Husky 1 North Dry Ridge Phosphate Mine Project Draft EIS by December 6, 2021. The BLM will hold a virtual public meeting on November 8, 2021, from 4:00 p.m. to 5:00 p.m. (Mountain Standard Time). Detailed information about how to participate in the meeting is available at: 
                        <E T="03">https://go.usa.gov/x7HSJ</E>
                         (case sensitive).
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments related to the Husky 1 North Dry Ridge Phosphate Mine Draft EIS by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Website: https://go.usa.gov/x7HSJ</E>
                         (case sensitive).
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Husky 1 North Dry Ridge Phosphate Mine Draft EIS, c/o Husky 1 North Dry Ridge Mine EIS, C/O Tetra Tech, 2525 Palmer Street, Suite 2, Missoula, MT 59808.
                    </P>
                    <P>Please reference “Husky 1 North Dry Ridge Phosphate Mine Draft EIS” on all correspondence. A digital version of Husky 1 North Dry Ridge Phosphate Mine Draft EIS is available at the project websites:</P>
                    <P>
                        • 
                        <E T="03">BLM Land Use Planning and NEPA Register: https://go.usa.gov/x7HSJ</E>
                         (case sensitive).
                    </P>
                    <P>
                        • Caribou-Targhee National Forest Current and Recent Projects 
                        <E T="03">http://www.fs.usda.gov/projects/ctnf/landmanagement/projects</E>
                        .
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Wes Gilmer, BLM Pocatello Field Office, 
                        <PRTPAGE P="58687"/>
                        4350 Cliffs Drive, Pocatello, ID 83204; telephone (208) 478-6369; email: 
                        <E T="03">wgilmer@blm.gov;</E>
                         fax (208) 478-6376. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact Mr. Gilmer. The FRS is available 24 hours a day, 7 days a week, to leave a message or question for Mr. Gilmer. You will receive a reply during normal business hours.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Itafos Conda LLC has submitted a Mine and Reclamation Plan (MRP) for agency review for Federal phosphate leases IDI-8289, IDI-05549, I-04 and IDI-0678 and a proposed modification (enlargement) of lease IDI-05549 at the proposed Husky 1 North Dry Ridge Phosphate Mine in Caribou County, Idaho. The BLM, as the Federal lease administrator, is the lead agency, and the USFS is the co-lead agency for preparing the EIS. The U.S. Army Corps of Engineers, Idaho Department of Environmental Quality, Idaho Department of Lands, and Idaho Governor's Office of Energy and Mineral Resources are cooperating agencies.</P>
                <P>The Proposed Action would mine the Federal phosphate leases as outlined in the Draft EIS. The Draft EIS evaluates alternatives to the proposed action, including a no action alternative, and addresses issues identified during public scoping.</P>
                <P>The BLM and USFS will make separate but coordinated decisions related to the proposed project. The BLM will approve, approve with modifications, or deny the MRP and lease modification. The BLM will base its decisions on public and agency input, any recommendations the USFS may have regarding surface management of leased National Forest System lands, and the Final EIS. The USFS will make recommendations to the BLM concerning surface management and mitigation on leased lands within the CTNF and will issue decisions on Special Use Authorizations for off-lease mine support activities. A Forest Plan amendment would also be necessary as outlined in the Draft EIS.</P>
                <P>
                    On December 23, 2020, the agencies published a Notice of Intent to prepare an EIS in the 
                    <E T="04">Federal Register</E>
                     initiating a 30-day public scoping period. The scoping process identified concerns related to impacts to water resources and watersheds from potentially elevated levels of selenium; effects to air quality, human health and safety, socioeconomics, and wildlife; reclamation and financial assurance; and mitigation and monitoring of mine operations.
                </P>
                <P>The agencies have planned a virtual public meeting to summarize the document and answer questions. The date, time, and instructions for attending the virtual public meeting will be announced on the project websites.</P>
                <P>Comments regarding the adequacy of the Draft EIS must be submitted by December 6, 2021. To assist the BLM and the USFS in identifying issues and concerns related to this project, comments should be as specific as possible.</P>
                <P>Note that the portion of the proposed project related to Special Use Authorizations for off-lease activities is subject to the USFS objection process. This proposed project may be subject to the pre-decisional administrative review process pursuant to 36 CFR 218 subparts A and B because Forest Plan amendments may be needed. Only those who provide comment during this comment period or who have previously submitted specific written comments on the Proposed Action, either during scoping or other designated opportunity for public comment, will be eligible as objectors (36 CFR 218.5(a) and 219.53 (a)). Appeal procedures found in 43 CFR 4 apply to any BLM decision on the MRP or lease modification related Federal mineral leases.</P>
                <P>Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.</P>
                <P>
                    <E T="03">Authority</E>
                    : 42 U.S.C. 4321 
                    <E T="03">et seq.;</E>
                     40 CFR 1500 through 1508; 43 CFR 46; 43 U.S.C. 1701; 43 CFR 3510; 43 CFR 3590.
                </P>
                <SIG>
                    <NAME>Todd Kuck,</NAME>
                    <TITLE>Acting District Manager, Idaho Falls District.</TITLE>
                    <NAME>Melvin Bolling,</NAME>
                    <TITLE>Forest Supervisor, Caribou-Targhee National Forest.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23027 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4310-GG-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Land Management</SUBAGY>
                <DEPDOC>[LLNVS01000.L12320000.DA0000.18X.LVRDNV08000; MO# 4500153073]</DEPDOC>
                <SUBJECT>Notice of Intent To Prepare a Resource Management Plan Amendment Environmental Assessment, Recreation Area Management Plan, and Travel Management Plan for Logandale Trails, Clark County, NV</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Land Management, Department of 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, the Bureau of Land Management (BLM), Las Vegas Field Office (LVFO), will prepare a Resource Management Plan Amendment Environmental Assessment (EA) for the proposed Logandale Trails Special Recreational Management Area, approximately 60 miles northeast of Las Vegas, Nevada, and west of the communities of Logandale and Overton, Nevada. This notice will include a Recreation Area Management Plan and a Travel Management Plan. Publication of this notice initiates the scoping process and opens a 30-day public comment period to solicit public comments and identify issues.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        This notice initiates the 30-day public scoping process for the proposed Resource Management Plan Amendment, Recreation Area Management Plan, route inventory, and Travel Management Plan that will assist in the preparation of the Draft EA. Comments on issues may be submitted in writing until November 22, 2021. The date(s) and location(s) of virtual meetings will be announced at least 15 days in advance through local news media and the BLM website at: 
                        <E T="03">https://www.blm.gov/office/las-vegas-field-office.</E>
                    </P>
                    <P>Comments must be received prior to the close of the scoping period or 15 days after the last public meeting, whichever is later, to be included in the Resource Management Plan Amendment EA. The BLM will provide an additional opportunity for public participation upon publication of the draft EA; this will include an in-person and/or virtual public meeting.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Submit comments related to the project by any of the following methods:</P>
                    <FP SOURCE="FP-1">
                        • 
                        <E T="03">Email: BLM_NV_LVFO_Logandale_RAMP@blm.gov</E>
                        <PRTPAGE P="58688"/>
                    </FP>
                    <FP SOURCE="FP-1">
                        • 
                        <E T="03">E-planning: https://eplanning.blm.gov/eplanning-ui/home,</E>
                         search for Resource Management Plan Amendment Environmental Assessment, Recreation Area Management Plan and Travel Management Plan for Logandale Trails
                    </FP>
                    <FP SOURCE="FP-1">
                        • 
                        <E T="03">Mail:</E>
                         BLM, Las Vegas Field Office, Attn: Kenny Kendrick, 4701 North Torrey Pines Drive, Las Vegas, NV 89130-2301
                    </FP>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For further information and/or to have your name added to the mailing list, send requests to Colleen Cepero Rios, Planning &amp; Environmental Coordinator, at telephone (702) 515-5395; or address, 4701 North Torrey Pines Drive, Las Vegas, NV 89130-2301; or email, 
                        <E T="03">cceperorios@blm.gov.</E>
                         Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The proposed Logandale Trails Special Recreational Management Area would include approximately 15,019 acres of lands managed by the BLM, located approximately 60 miles northeast of Las Vegas, Nevada, bound to the east by the communities of Logandale and Overton, Nevada. The purpose of the public scoping process is to determine relevant issues that will influence the scope of the environmental analysis, including alternatives, and guide the process for developing the Resource Management Plan Amendment EA. BLM has identified the following preliminary issues: Threatened and endangered species, sensitive plant and wildlife species, vegetation, noxious weeds, cultural resources, recreation, mineral entry, sensitive soils, and private inholdings.</P>
                <P>The BLM will consult with Native American tribes on a government-to-government basis in accordance with Executive Order 13175, Memorandum on Tribal Consultation and Strengthening Nation-to-Nation Relationships (86 FR 7491), and other policies. Native American tribal consultation will be conducted in accordance with policy, and tribal concerns will be given due consideration, including impacts on Indian Trust assets. Federal, State, and local agencies, along with other 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.</P>
                <P>Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.</P>
                <P>The lands included in this notice are legally described as follows:</P>
                <EXTRACT>
                    <HD SOURCE="HD1">Mount Diablo Meridian, Nevada</HD>
                    <FP SOURCE="FP-2">T. 16 S., R. 66 E.,</FP>
                    <FP SOURCE="FP1-2">
                        Sec. 12, E
                        <FR>1/2</FR>
                        NE
                        <FR>1/4</FR>
                         and E
                        <FR>1/2</FR>
                        SE
                        <FR>1/4</FR>
                        ;
                    </FP>
                    <FP SOURCE="FP1-2">
                        Sec. 13, E
                        <FR>1/2</FR>
                        NE
                        <FR>1/4</FR>
                        , NE
                        <FR>1/4</FR>
                        SE
                        <FR>1/4</FR>
                        , and S
                        <FR>1/2</FR>
                        SE
                        <FR>1/4</FR>
                        ;
                    </FP>
                    <FP SOURCE="FP1-2">
                        Sec. 24, E
                        <FR>1/2</FR>
                        .
                    </FP>
                    <FP SOURCE="FP-2">T. 15 S., R. 67 E.,</FP>
                    <FP SOURCE="FP1-2">
                        Sec. 31, E
                        <FR>1/2</FR>
                        NE
                        <FR>1/4</FR>
                        , E
                        <FR>1/2</FR>
                        SE
                        <FR>1/4</FR>
                        SW
                        <FR>1/4</FR>
                        , and SE
                        <FR>1/4</FR>
                        ;
                    </FP>
                    <FP SOURCE="FP1-2">Secs. 32 and 33;</FP>
                    <FP SOURCE="FP1-2">
                        Sec. 34, SW
                        <FR>1/4</FR>
                        NW
                        <FR>1/4</FR>
                         and W
                        <FR>1/2</FR>
                        SW
                        <FR>1/4</FR>
                        .
                    </FP>
                    <FP SOURCE="FP-2">T. 16 S., R. 67 E.,</FP>
                    <FP SOURCE="FP1-2">
                        Sec. 3, lots 3 and 4, SW
                        <FR>1/4</FR>
                        NE
                        <FR>1/4</FR>
                        , S
                        <FR>1/2</FR>
                        NW
                        <FR>1/4</FR>
                        , SW
                        <FR>1/4</FR>
                        , and W
                        <FR>1/2</FR>
                        SE
                        <FR>1/4</FR>
                    </FP>
                    <FP SOURCE="FP1-2">Sec. 4;</FP>
                    <FP SOURCE="FP1-2">
                        Sec. 5, lots 1 thru 4, S
                        <FR>1/2</FR>
                        NE
                        <FR>1/4</FR>
                        , S
                        <FR>1/2</FR>
                        NW
                        <FR>1/4</FR>
                        , W
                        <FR>1/2</FR>
                        NW
                        <FR>1/4</FR>
                        SW
                        <FR>1/4</FR>
                        , W
                        <FR>1/2</FR>
                        SW
                        <FR>1/4</FR>
                        SW
                        <FR>1/4</FR>
                        , and SE
                        <FR>1/4</FR>
                        ;
                    </FP>
                    <FP SOURCE="FP1-2">Secs. 6 thru 9;</FP>
                    <FP SOURCE="FP1-2">
                        Sec. 10, W
                        <FR>1/2</FR>
                        NE
                        <FR>1/4</FR>
                        , SE
                        <FR>1/4</FR>
                        NE
                        <FR>1/4</FR>
                        , W
                        <FR>1/2</FR>
                        , and SE
                        <FR>1/4</FR>
                        ;
                    </FP>
                    <FP SOURCE="FP1-2">Secs. 15 thru 23;</FP>
                    <FP SOURCE="FP1-2">Sec. 26;</FP>
                    <FP SOURCE="FP1-2">
                        Sec. 27, NE
                        <FR>1/4</FR>
                        , E
                        <FR>1/2</FR>
                        NW
                        <FR>1/4</FR>
                        , and SE
                        <FR>1/4</FR>
                        ;
                    </FP>
                    <FP SOURCE="FP1-2">Sec. 28;</FP>
                    <FP SOURCE="FP1-2">
                        Sec. 29, NE
                        <FR>1/4</FR>
                        , E
                        <FR>1/2</FR>
                        NW
                        <FR>1/4</FR>
                        , E
                        <FR>1/2</FR>
                        SW
                        <FR>1/4</FR>
                        , and SE
                        <FR>1/4</FR>
                        . 
                    </FP>
                    <FP>(Authority: 40 CFR 1506.6, 40 CFR 1506.10, 43 CFR 1610.2; 43 CFR 1610.5)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Shonna Dooman,</NAME>
                    <TITLE>Las Vegas Field Manager. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23083 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4310-HC-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>National Park Service</SUBAGY>
                <DEPDOC>[NPS-WASO-NRNHL-DTS#-32872; PPWOCRADI0, PCU00RP14.R50000]</DEPDOC>
                <SUBJECT>National Register of Historic Places; Notification of Pending Nominations and Related Actions</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Park Service, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The National Park Service is soliciting electronic comments on the significance of properties nominated before October 9, 2021, for listing or related actions in the National Register of Historic Places.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments should be submitted electronically by November 8, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments are encouraged to be submitted electronically to 
                        <E T="03">National_Register_Submissions@nps.gov</E>
                         with the subject line “Public Comment on &lt;property or proposed district name, (County) State&gt;.” If you have no access to email you may send them via U.S. Postal Service and all other carriers to the National Register of Historic Places, National Park Service, 1849 C Street NW, MS 7228, Washington, DC 20240.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Sherry A. Frear, Chief, National Register of Historic Places/National Historic Landmarks Program, 1849 C Street NW, MS 7228, Washington, DC 20240, 
                        <E T="03">sherry_frear@nps.gov,</E>
                         202-913-3763.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The properties listed in this notice are being considered for listing or related actions in the National Register of Historic Places. Nominations for their consideration were received by the National Park Service before October 9, 2021. Pursuant to Section 60.13 of 36 CFR part 60, comments are being accepted concerning the significance of the nominated properties under the National Register criteria for evaluation.</P>
                <P>Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.</P>
                <P>Nominations submitted by State or Tribal Historic Preservation Officers:</P>
                <EXTRACT>
                    <HD SOURCE="HD1">ARIZONA</HD>
                    <HD SOURCE="HD1">Maricopa County</HD>
                    <FP SOURCE="FP-1">Wright, David and Gladys, House, 405 North Rubicon Ave. (formally 5212 East Exeter Blvd.), Phoenix, SG100007156</FP>
                    <FP SOURCE="FP-1">Valley National Bank Branch No. 10, 1845 East McDowell Rd., Phoenix, SG100007157</FP>
                    <HD SOURCE="HD1">ILLINOIS</HD>
                    <HD SOURCE="HD1">Cook County</HD>
                    <FP SOURCE="FP-1">State of Illinois Center, 100 West Randolph St., Chicago, SG100007140</FP>
                    <HD SOURCE="HD1">IOWA</HD>
                    <HD SOURCE="HD1">Dallas County</HD>
                    <FP SOURCE="FP-1">
                        Dayton Stagecoach Inn and Tavern Historic District, 14750 Pecos Ct., Bouton vicinity, SG100007139
                        <PRTPAGE P="58689"/>
                    </FP>
                    <HD SOURCE="HD1">MASSACHUSETTS</HD>
                    <HD SOURCE="HD1">Suffolk County</HD>
                    <FP SOURCE="FP-1">Humboldt Avenue Historic District, 249, 257, 259 Humboldt Ave. and 79-83, 94 Hutchings St., Boston, SG100007147</FP>
                    <HD SOURCE="HD1">MONTANA</HD>
                    <HD SOURCE="HD1">Mineral County</HD>
                    <FP SOURCE="FP-1">St. Regis Airway Beacon, (Sentinels of the Airways: Montana's Airway Beacon System, 1934-1979 MPS), 2 mi. SE of St. Regis, St. Regis vicinity, MP100007145</FP>
                    <HD SOURCE="HD1">NEBRASKA</HD>
                    <HD SOURCE="HD1">Harlan County</HD>
                    <P>Alma Carnegie Library, (Carnegie Libraries in Nebraska MPS AD), 111 North John St., Alma, MP100007149</P>
                    <HD SOURCE="HD1">Madison County</HD>
                    <FP SOURCE="FP-1">Norfolk Masonic Temple, 907 Norfolk Ave., Norfolk, SG100007150</FP>
                    <HD SOURCE="HD1">Otoe County</HD>
                    <FP SOURCE="FP-1">Palmyra Pioneer Cemetery, Jct. of Giles and North 10th Rds., Palmyra vicinity, SG100007151</FP>
                    <HD SOURCE="HD1">NEW YORK</HD>
                    <HD SOURCE="HD1">Erie County</HD>
                    <FP SOURCE="FP-1">American Grain Complex (Boundary Increase), (Buffalo Grain and Materials Elevator MPS), 100 Childs St. aka 145 Buffalo River, Buffalo, BC100007137</FP>
                    <HD SOURCE="HD1">Monroe County</HD>
                    <FP SOURCE="FP-1">J. Hungerford Smith Company Factory, 410 North Goodman and 1115 East Main Sts., Rochester, SG100007141</FP>
                    <HD SOURCE="HD1">PENNSYLVANIA</HD>
                    <HD SOURCE="HD1">Franklin County</HD>
                    <FP SOURCE="FP-1">Peerless Furniture Company, 40 Lurgan Ave., Shippensburg, SG100007142</FP>
                    <HD SOURCE="HD1">VIRGINIA</HD>
                    <HD SOURCE="HD1">Campbell County</HD>
                    <FP SOURCE="FP-1">Mead's Tavern, 594 Alum Springs Rd., Lynchburg vicinity, SG100007133</FP>
                    <HD SOURCE="HD1">Fauquier County</HD>
                    <FP SOURCE="FP-1">Vint Hill Farms Station Historic District, Aiken Dr., Kennedy Rd., Vint Hill Pkwy., Farm Station Rd., Bludau Dr., Sigler Rd., Warrenton, SG100007135</FP>
                    <HD SOURCE="HD1">Richmond County</HD>
                    <FP SOURCE="FP-1">Chinn House, 5554 Richmond Rd., Warsaw, SG100007134</FP>
                    <HD SOURCE="HD1">WISCONSIN</HD>
                    <HD SOURCE="HD1">Dane County</HD>
                    <FP SOURCE="FP-1">Edwards-Larson House, 6003 Exchange St., McFarland, SG100007138</FP>
                    <FP SOURCE="FP-1">Depot Hill Historic District, Roughly along E. Main St., Stoughton, 98000222</FP>
                    <HD SOURCE="HD1">La Crosse County</HD>
                    <FP SOURCE="FP-1">Wright, Razy and John, House, W5670 Cty. Rd. F, Medary, SG100007152</FP>
                </EXTRACT>
                <P>Additional documentation has been received for the following resources:</P>
                <EXTRACT>
                    <HD SOURCE="HD1">MARYLAND</HD>
                    <HD SOURCE="HD1">Baltimore Independent City</HD>
                    <FP SOURCE="FP-1">Clifton Park, Bounded by Hartford Rd., Erdman Ave., Clifton Park Terrace, the Baltimore Belt RR and Sinclair Ln., Baltimore, AD07000941</FP>
                    <HD SOURCE="HD1">MASSACHUSETTS</HD>
                    <HD SOURCE="HD1">Plymouth County</HD>
                    <FP SOURCE="FP-1">Kingston Center Historic District, Main, Green Sts., Kingston, AD02001085</FP>
                    <HD SOURCE="HD1">NEW YORK</HD>
                    <HD SOURCE="HD1">Erie County</HD>
                    <FP SOURCE="FP-1">American Grain Complex (Additional Documentation), (Buffalo Grain and Materials Elevator MPS), 100 Childs St. aka 145 Buffalo River, Buffalo, AD12000475</FP>
                </EXTRACT>
                <P>
                    <E T="03">Authority:</E>
                     Section 60.13 of 36 CFR part 60.
                </P>
                <SIG>
                    <DATED>Dated: October 13, 2021.</DATED>
                    <NAME>Sherry A. Frear,</NAME>
                    <TITLE>Chief, National Register of Historic Places/National Historic Landmarks Program.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23015 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4312-52-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF JUSTICE</AGENCY>
                <SUBAGY>Antitrust Division</SUBAGY>
                <SUBJECT>Notice Pursuant to the National Cooperative Research and Production Act of 1993—MLCommons Association</SUBJECT>
                <P>
                    Notice is hereby given that on September 23, 2021 pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 
                    <E T="03">et seq.</E>
                     (the “Act”), MLCommons Association (“MLCommons”) has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing changes in its membership. The notifications were filed for the purpose of extending the Act's provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Specifically, Femtosense, Inc., Palo Alto, CA; Sebastian Magierowski (individual member), Toronto, CANADA; Oana Balmau (individual member), Montreal, CANADA; Jeffrey Mao (individual member), Union City, CA; Maxwell Labs Inc., New Hope, MN; and Anh Nguyen (individual member), Munich, GERMANY have joined as parties to this venture.
                </P>
                <P>No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open and MLCommons intends to file additional written notifications disclosing all changes in membership.</P>
                <P>
                    On September 15, 2020, MLCommons filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the 
                    <E T="04">Federal Register</E>
                     pursuant to Section 6(b) of the Act on September 29, 2020 (85 FR 61032).
                </P>
                <P>
                    The last notification was filed with the Department on July 12, 2021. A notice was published in the 
                    <E T="04">Federal Register</E>
                     pursuant to Section 6(b) of the Act on August 23, 2021 (86 FR 47151).
                </P>
                <SIG>
                    <NAME>Suzanne Morris,</NAME>
                    <TITLE>Chief, Premerger and Division Statistics, Antitrust Division.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23096 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4410-11-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF JUSTICE</AGENCY>
                <SUBAGY>Antitrust Division</SUBAGY>
                <SUBJECT>Notice Pursuant to the National Cooperative Research and Production Act of 1993-Robotic Operating System-Military Standards Development Organization</SUBJECT>
                <P>
                    Notice is hereby given that, on September 14, 2021, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 
                    <E T="03">et seq.</E>
                     (“the Act”), Robotic Operating System-Military Standards Development Organization (“ROS-M SDO”) has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing (1) the name and principal place of business of the standards development organization and (2) the nature and scope of its standards development activities. The notifications were filed for the purpose of invoking the Act's provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances.
                </P>
                <P>
                    Pursuant to Section 6(b) of the Act, the name and principal place of business of the standards development organization is: Robotic Operating System-Military Standards Development Organization, Ann Arbor, MI. The nature and scope of ROS-M SDO's standards development activities are: The ROS-M SDO is comprised of members of National Advanced Mobility Consortium (“NAMC”) that are engaged in developing a software ecosystem for military robotic and autonomous systems (RAS) that provides a trusted community of Government and industry developers with the artifacts and other means to develop, grow, and maintain a federated body of re-useable software components for defense robotics systems. The ROS-
                    <PRTPAGE P="58690"/>
                    M ecosystem includes a library and registry of military-relevant software components compatible with the open ROS framework, development tools, documentation, and support services.
                </P>
                <SIG>
                    <NAME>Suzanne Morris,</NAME>
                    <TITLE>Chief, Premerger and Division Statistics, Antitrust Division.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23095 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4410-11-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF JUSTICE</AGENCY>
                <SUBAGY>Antitrust Division</SUBAGY>
                <SUBJECT>Notice Pursuant to The National Cooperative Research and Production Act of 1993—3D PDF CONSORTIUM, Inc.</SUBJECT>
                <P>
                    Notice is hereby given that, on October 4, 2021, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 
                    <E T="03">et seq.</E>
                     (“the Act”), 3D PDF Consortium, Inc. (“3D PDF”) has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing changes in its membership. The notifications were filed for the purpose of extending the Act's provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Specifically, Kubotek3D, Marlborough, MA; Library of Congress, Washington, DC; U.S. National Archives and Records Administration (NARA), New York, NY; Advanced Technology International, Summerville, SC; Elysium Co. Ltd., Shizuoka, JAPAN; PDFTron Systems Inc., Vancouver, CANADA; Purdue University, West Lafayette, IN; Datakit SARL, Lyon, FRANCE; Theorem Solutions Ltd., Staffordshire, UNITED KINGDOM; The Boeing Company, Seattle, WA; ITI, a Wipro company (previously ITI TranscenData Business), Milford, OH; Anark Corporation, Boulder, CO; PROSTEP AG, Darmstadt, GERMANY; and Tech Soft 3D, Bend, OR, have withdrawn as parties to this venture.
                </P>
                <P>No other changes have been made in either the membership or planned activity of the group research project.</P>
                <P>
                    On March 27, 2012, 3D PDF filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the 
                    <E T="04">Federal Register</E>
                     pursuant to Section 6(b) of the Act on April 20, 2012 (77 FR 23754).
                </P>
                <P>
                    The last notification was filed with the Department on July 7, 2021. A notice was published in the 
                    <E T="04">Federal Register</E>
                     pursuant to Section 6(b) of the Act on August 23, 2021 (86 FR 47150).
                </P>
                <SIG>
                    <NAME>Suzanne Morris,</NAME>
                    <TITLE>Chief, Premerger and Division Statistics, Antitrust Division.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23101 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4410-11-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF JUSTICE</AGENCY>
                <SUBAGY>Antitrust Division</SUBAGY>
                <SUBJECT>Notice Pursuant to the National Cooperative Research and Production Act of 1993—ASTM International Standards</SUBJECT>
                <P>
                    Notice is hereby given that on September 15, 2021 pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 
                    <E T="03">et seq.</E>
                     (“the Act”), ASTM International(“ASTM”) has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing additions or changes to its standards development activities.
                </P>
                <P>
                    The notifications were filed for the purpose of extending the Act's provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Specifically, ASTM has provided an updated list of current, ongoing ASTM activities originating between May 24, 2021 and September 15, 2021 designated as Work Items. A complete listing of ASTM Work Items, along with a brief description of each, is available at 
                    <E T="03">http://www.astm.org.</E>
                </P>
                <P>
                    On September 15, 2004, ASTM filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the 
                    <E T="04">Federal Register</E>
                     pursuant to Section 6(b) of the Act on November 10, 2004 (69 FR 65226).
                </P>
                <P>
                    The last notification with the Department was filed on May 27, 2021. A notice was filed in the 
                    <E T="04">Federal Register</E>
                     on July 26,2021 (86 FR 40079).
                </P>
                <SIG>
                    <NAME>Suzanne Morris,</NAME>
                    <TITLE>Chief, Premerger and Division Statistics, Antitrust Division, Department of Justice.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23105 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4410-11-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF JUSTICE</AGENCY>
                <SUBAGY>Antitrust Division</SUBAGY>
                <SUBJECT>Notice Pursuant to The National Cooperative Research and Production Act of 1993—ODVA, Inc.</SUBJECT>
                <P>
                    Notice is hereby given that, on October 5, 2021, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 
                    <E T="03">et seq.</E>
                     (“the Act”), ODVA, Inc. (“ODVA”) has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing changes in its membership. The notifications were filed for the purpose of extending the Act's provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Specifically, AGI Suretrack, LLC, Lenexa, KS; JingQi (Tianjin) Technology Co. Ltd., Tianjin, PEOPLE'S REPUBLIC OF CHINA; Blue-White Industries Ltd., Huntington Beach, CA; Inxpect SPA Core Tigo LTD, Brescia, ITALY; Super Systems, Inc., Cincinnati, OH; Fluke Electronics Corporation, Everett, WA; Wachendorff Automation GmbH &amp; Co., KG, Geisenheim, GERMANY; and Soft Robotics Inc., Bedford, MA, have been added as parties to this venture.
                </P>
                <P>Also, RIFTEK LLC, Minsk, BELARUS; Conch Electronic Co. Ltd., Tainan City Taiwan, PEOPLE'S REPUBLIC OF CHINA; swisca ag, Appenzell, SWITZERLAND; IDEC Corporation, Osaka, JAPAN; and Woodward, Inc., Ft. Collins, CO, have withdrawn as parties to this venture.</P>
                <P>No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and ODVA intends to file additional written notifications disclosing all changes in membership.</P>
                <P>
                    On June 21, 1995, ODVA filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the 
                    <E T="04">Federal Register</E>
                     pursuant to Section 6(b) of the Act on February 15, 1996 (61 FR 6039).
                </P>
                <P>
                    The last notification was filed with the Department on July 12, 2021. A notice was published in the 
                    <E T="04">Federal Register</E>
                     pursuant to Section 6(b) of the Act on August 23, 2021 (86 FR 47150).
                </P>
                <SIG>
                    <NAME>Suzanne Morris,</NAME>
                    <TITLE>Chief, Premerger and Division Statistics, Antitrust Division.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23099 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4410-11-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="58691"/>
                <AGENCY TYPE="S">DEPARTMENT OF JUSTICE</AGENCY>
                <SUBAGY>Antitrust Division</SUBAGY>
                <SUBJECT>Notice Pursuant to the National Cooperative Research and Production Act of 1993—Electrified Vehicle and Energy Storage Evaluation</SUBJECT>
                <P>
                    Notice is hereby given that, on September 21, 2021, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 
                    <E T="03">et seq.</E>
                     (“the Act”), Electrified Vehicle and Energy Storage Evaluation (“EVESE”) has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing changes in its membership. The notifications were filed for the purpose of extending the Act's provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Specifically, LG Energy Solution, Ltd., Seoul, KOREA, has been added as a party to this venture.
                </P>
                <P>No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and EVESE intends to file additional written notifications disclosing all changes in membership.</P>
                <P>
                    On September 24, 2020, EVESE filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the 
                    <E T="04">Federal Register</E>
                     pursuant to Section 6(b) of the Act on October 15, 2020 (85 FR 65423).
                </P>
                <P>
                    The last notification was filed with the Department on July 27, 2021. A notice was published in the 
                    <E T="04">Federal Register</E>
                     pursuant to Section 6(b) of the Act on August 23, 2021 (86 FR 47157).
                </P>
                <SIG>
                    <NAME>Suzanne Morris,</NAME>
                    <TITLE>Chief, Premerger and Division Statistics, Antitrust Division.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23098 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4410-11-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF JUSTICE</AGENCY>
                <SUBAGY>Drug Enforcement Administration</SUBAGY>
                <DEPDOC>[Docket No. DEA-913]</DEPDOC>
                <SUBJECT>Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Drug Enforcement Administration, Justice.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of application.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        Chattem Chemicals has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         listed below for further drug information.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before December 21, 2021. Such persons may also file a written request for a hearing on the application on or before December 21, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.</P>
                </ADD>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>In accordance with 21 CFR 1301.33(a), this is notice that on July 23, 2021, Chattem Chemicals, 3801 Saint Elmo Avenue, Chattanooga, Tennessee 37409-1237, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):</P>
                <GPOTABLE COLS="3" OPTS="L2,tp0,p7,7/8,i1" CDEF="s25,5,xls32">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Controlled substance</CHED>
                        <CHED H="1">
                            Drug
                            <LI>code</LI>
                        </CHED>
                        <CHED H="1">Schedule</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Gamma Hydroxybutyric Acid</ENT>
                        <ENT>2010</ENT>
                        <ENT>I</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Marihuana</ENT>
                        <ENT>7360</ENT>
                        <ENT>I</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Tetrahydrocannabinols</ENT>
                        <ENT>7370</ENT>
                        <ENT>I</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">4-Methoxyamphetamine</ENT>
                        <ENT>7411</ENT>
                        <ENT>I</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Noroxymorphone</ENT>
                        <ENT>9145</ENT>
                        <ENT>I</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Amphetamine</ENT>
                        <ENT>1100</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Methamphetamine</ENT>
                        <ENT>1105</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Lisdexamfetamine</ENT>
                        <ENT>1205</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Methylphenidate</ENT>
                        <ENT>1724</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Cocaine</ENT>
                        <ENT>9041</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Codeine</ENT>
                        <ENT>9050</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Dihydrocodeine</ENT>
                        <ENT>9120</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Oxycodone</ENT>
                        <ENT>9143</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Hydromorphone</ENT>
                        <ENT>9150</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Ecgonine</ENT>
                        <ENT>9180</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Hydrocodone</ENT>
                        <ENT>9193</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Levorphanol</ENT>
                        <ENT>9220</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Methadone</ENT>
                        <ENT>9250</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Methadone intermediate</ENT>
                        <ENT>9254</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Morphine</ENT>
                        <ENT>9300</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Oripavine</ENT>
                        <ENT>9330</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Thebaine</ENT>
                        <ENT>9333</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Oxymorphone</ENT>
                        <ENT>9652</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Noroxymorphone</ENT>
                        <ENT>9668</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Alfentanil</ENT>
                        <ENT>9737</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Remifentanil</ENT>
                        <ENT>9739</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Sufentanil</ENT>
                        <ENT>9740</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Tapentadol</ENT>
                        <ENT>9780</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Fentanyl</ENT>
                        <ENT>9801</ENT>
                        <ENT>II</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The company plans to manufacture the listed controlled substances in bulk for distribution and sale to its customers. In reference to drug code 7360 (Marihuana) and 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture these drugs as a synthetic.</P>
                <P>No other activities for this drug code are authorized for this registration.</P>
                <SIG>
                    <NAME>Brian S. Besser,</NAME>
                    <TITLE>Acting Assistant Administrator. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23037 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF JUSTICE</AGENCY>
                <SUBAGY>Drug Enforcement Administration</SUBAGY>
                <DEPDOC>[Docket No. DEA-919]</DEPDOC>
                <SUBJECT>Importer of Controlled Substances Application: Mycrodose Therapeutics</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Drug Enforcement Administration, Justice.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of application.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Mycrodose Therapeutics has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before November 22, 2021. Such persons may also file a written request for a hearing on the application on or before November 22, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for a hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.</P>
                </ADD>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>In accordance with 21 CFR 1301.34(a), this is notice that on September 17, 2021, Mycrodose Therapeutics, 5940 Pacific Mesa Court, Suite 210, San Diego, California 92121-4317 applied to be registered as an importer of the following basic class(es) of controlled substance(s):</P>
                <GPOTABLE COLS="3" OPTS="L2,tp0,i1" CDEF="s25,5,xs34">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Controlled substance</CHED>
                        <CHED H="1">Drug code</CHED>
                        <CHED H="1">Schedule</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Psilocybin</ENT>
                        <ENT>7437</ENT>
                        <ENT>I</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Psilocyn</ENT>
                        <ENT>7438</ENT>
                        <ENT>I</ENT>
                    </ROW>
                </GPOTABLE>
                <PRTPAGE P="58692"/>
                <P>The company plans to import the listed control substances for clinical trials, research and development, analytical purposes, and distribution to its customers. No other activity for these drug codes is authorized for this registration.</P>
                <P>Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.</P>
                <SIG>
                    <NAME>Brian S. Besser,</NAME>
                    <TITLE>Acting Assistant Administrator.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23036 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF JUSTICE</AGENCY>
                <SUBAGY>Drug Enforcement Administration</SUBAGY>
                <DEPDOC>[Docket No. DEA-912]</DEPDOC>
                <SUBJECT>Bulk Manufacturer of Controlled Substances Application: Groff NA Hemplex LLC</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Drug Enforcement Administration, Justice.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of application.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        Groff NA Hemplex LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to 
                        <E T="02">Supplementary Information</E>
                         listed below for further drug information.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before December 21, 2021. Such persons may also file a written request for a hearing on the application on or before December 21, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.</P>
                </ADD>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>In accordance with 21 CFR 1301.33(a), this is notice that on August 16, 2021, Groff NA Hemplex LLC, 100 Redco Avenue, Suite A, Red Lion, Pennsylvania 17356-1436, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):</P>
                <GPOTABLE COLS="3" OPTS="L2,tp0,i1" CDEF="s25,4,xs36">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Controlled substance</CHED>
                        <CHED H="1">
                            Drug
                            <LI>code</LI>
                        </CHED>
                        <CHED H="1">Schedule</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Marihuana Extract</ENT>
                        <ENT>7350</ENT>
                        <ENT>I</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Marihuana</ENT>
                        <ENT>7360</ENT>
                        <ENT>I</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Tetrahydrocannabinols</ENT>
                        <ENT>7370</ENT>
                        <ENT>I</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The company is federally authorized to conduct cultivation activities in order to bulk manufacture the listed controlled substances for internal use and for sale to federally registered research investigators. No other activities for these drug codes are authorized for this registration.</P>
                <SIG>
                    <NAME>Brian S. Besser,</NAME>
                    <TITLE>Acting Assistant Administrator.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23034 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF JUSTICE</AGENCY>
                <SUBAGY>Drug Enforcement Administration</SUBAGY>
                <DEPDOC>[Docket No. DEA-914]</DEPDOC>
                <SUBJECT>Bulk Manufacturer of Controlled Substances Application: Organic Consultants, LLC. DBA Cascade Chemistry</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Drug Enforcement Administration, Justice.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of application.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Organic Consultants, LLC. DBA Cascade Chemistry, has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before December 21, 2021. Such persons may also file a written request for a hearing on the application on or before December 21, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.</P>
                </ADD>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>In accordance with 21 CFR 1301.33(a), this is notice that on September 9, 2021, Organic Consultants, LLC. DBA Cascade Chemistry, 90 North Polk Street, Suite 200, Eugene, Oregon 97402-4109, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):</P>
                <GPOTABLE COLS="3" OPTS="L2,tp0,i1" CDEF="s25,5,xs34">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Controlled substance</CHED>
                        <CHED H="1">Drug code</CHED>
                        <CHED H="1">Schedule</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Amphetamine</ENT>
                        <ENT>1100</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Methylphenidate</ENT>
                        <ENT>1724</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Nabilone</ENT>
                        <ENT>7379</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Codeine</ENT>
                        <ENT>9050</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Oxycodone</ENT>
                        <ENT>9143</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Hydromorphone</ENT>
                        <ENT>9150</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Hydrocodone</ENT>
                        <ENT>9193</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Methadone</ENT>
                        <ENT>9250</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Methadone intermediate</ENT>
                        <ENT>9254</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Morphine</ENT>
                        <ENT>9300</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Thebaine</ENT>
                        <ENT>9333</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Oxymorphone</ENT>
                        <ENT>9652</ENT>
                        <ENT>II</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Fentanyl</ENT>
                        <ENT>9801</ENT>
                        <ENT>II</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The company plans to bulk manufacture small quantities of the listed controlled substances for internal use or for sale as analytical reference standard materials to its customers. No other activities for these drug codes are authorized for this registration.</P>
                <SIG>
                    <NAME>Brian S. Besser,</NAME>
                    <TITLE>Acting Assistant Administrator.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23038 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF JUSTICE</AGENCY>
                <SUBAGY>Drug Enforcement Administration</SUBAGY>
                <DEPDOC>[Docket No. DEA-911]</DEPDOC>
                <SUBJECT>Importer of Controlled Substances Application: Novitium Pharma LLC</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Drug Enforcement Administration, Justice.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of application.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Novitium Pharma LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before November 22, 2021. Such persons may also file a written request for a hearing on the application on or before November 22, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also be sent to: (1) Drug Enforcement Administration, Attn: 
                        <PRTPAGE P="58693"/>
                        Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
                    </P>
                </ADD>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>In accordance with 21 CFR 1301.34(a), this is notice that on September 8, 2021, Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, applied to be registered as an importer of the following basic class(es) of controlled substance(s):</P>
                <GPOTABLE COLS="3" OPTS="L2,tp0,i1" CDEF="s20,4,xs36">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Controlled substance</CHED>
                        <CHED H="1">
                            Drug
                            <LI>code</LI>
                        </CHED>
                        <CHED H="1">Schedule</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Levorphanol</ENT>
                        <ENT>9220</ENT>
                        <ENT>II</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The company plans to import the listed controlled substance Levorphanol to develop the manufacturing process for a drug product that will in turn be used to produce a tablet equivalent to the current brand product. No other activity for this drug code is authorized for this registration.</P>
                <P>Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.</P>
                <SIG>
                    <NAME>Brian S. Besser,</NAME>
                    <TITLE>Acting Assistant Administrator.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23032 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF JUSTICE</AGENCY>
                <SUBJECT>Service Contract Inventory; Notice of Availability</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Justice Management Division, Department of Justice.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Department of Justice is publishing this notice to advise the public of the availability of its FY 2019 Service Contracts Inventory and Inventory Supplement. The inventory includes service contract actions over $25,000 that were awarded in Fiscal Year (FY) 2019. The inventory supplement includes information collected from contractors on the amount invoiced and direct labor hours expended for covered service contracts. The Department of Justice analyzes this data for the purpose of determining whether its contract labor is being used in an effective and appropriate manner and if the mix of federal employees and contractors in the agency is effectively balanced. The inventory and supplement do not include contractor proprietary or sensitive information. The FY 2019 Service Contract Inventory and Inventory Supplements are provided at the following link: 
                        <E T="03">https://www.justice.gov/jmd/service-contractinventory.</E>
                    </P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Kevin Doss, Office of Acquisition Management, Justice Management Division, U.S. Department of Justice, Washington, DC 20530; Phone: 202-616-3758; Email: 
                        <E T="03">Kevin.Doss@usdoj.gov.</E>
                    </P>
                    <P>
                        <E T="03">Authority:</E>
                         Section 743 of Division C of the FY 2010 Consolidated Appropriations Act, Pub. L. 111-117.
                    </P>
                    <SIG>
                        <DATED>Dated: October 18, 2021.</DATED>
                        <NAME>Melody Braswell,</NAME>
                        <TITLE>Department Clearance Officer for PRA, U.S. Department of Justice.</TITLE>
                    </SIG>
                </FURINF>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23014 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4410-02-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Occupational Safety and Health Administration</SUBAGY>
                <DEPDOC>[Docket No. OSHA-2021-0010]</DEPDOC>
                <SUBJECT>Federal Advisory Council on Occupational Safety and Health</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 reestablishment of the Federal Advisory Council on Occupational Safety and Health (hereinafter FACOSH or Council) and request for nominations to serve on FACOSH.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Occupational Safety and Health Administration (OSHA) hereby announces that the Federal Advisory Council on Occupational Safety and Health (FACOSH) has been reestablished for a two-year period pursuant to the Federal Advisory Committee Act (FACA) and in accordance with the Committee Management Secretariat, General Services Administration. In addition, the Secretary of Labor (Secretary) requests nominations for membership on FACOSH.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit (postmark, send, transmit) nominations for FACOSH membership by November 22, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit nominations and supporting materials by one of the following methods:</P>
                    <P>
                        <E T="03">Electronically:</E>
                         You may submit nominations, including attachments, electronically into Docket No. OSHA—2021-0010 at 
                        <E T="03">http://www.regulations.gov,</E>
                         which is the Federal eRulemaking Portal. Follow the online instructions for submissions.
                    </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 the OSHA docket number for this 
                        <E T="04">Federal Register</E>
                         notice (OSHA-2021-0010). OSHA will place comments and requests to speak, including personal information, in the public docket, which may be available online. Therefore, OSHA cautions interested parties about submitting personal information such as Social Security numbers and birthdates.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P/>
                    <P>
                        <E T="03">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">General information:</E>
                         Mr. Francis Yebesi, Director, OSHA Office of Federal Agency Programs; telephone (202) 693-2122; email 
                        <E T="03">ofap@dol.gov.</E>
                    </P>
                    <P>
                        <E T="03">Copies of this</E>
                          
                        <E T="04">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">http://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">http://www.osha.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    On September 30, 2021, President Joseph Biden signed Executive Order (E.O.) 14048 continuing or reestablishing certain federal advisory committees, including FACOSH, until September 30, 2023 (86 FR 55465 (10/05/2021)). In response, the Secretary reestablished FACOSH and the Department of Labor (DOL) filed the FACOSH charter on October 14, 2021. FACOSH will terminate on September 30, 2023, unless continued by the President. The FACOSH charter is available to read or download at 
                    <E T="03">https://www.osha.gov/.</E>
                     In addition, the Secretary invites interested persons to submit nominations for membership on FACOSH.
                    <PRTPAGE P="58694"/>
                </P>
                <HD SOURCE="HD1">A. Background</HD>
                <P>FACOSH is authorized to advise the Secretary on all matters relating to the occupational safety and health of federal employees (5 U.S.C. 7902; 29 U.S.C. 668, Executive Order 12196, as amended). This includes providing advice on how to reduce and keep to a minimum the number of injuries and illnesses in the federal workforce, and how to encourage the establishment and maintenance of effective occupational safety and health programs in each federal agency.</P>
                <HD SOURCE="HD1">B. FACOSH Membership</HD>
                <P>
                    DOL invites nominations from a diverse range of qualified candidates to be considered for appointment to FACOSH. The Council was chartered to provide advice relating to the occupational safety and health of federal employees. This notice solicits nominations to fill sixteen vacancies; eight are members representing federal departments and agencies (management members), and eight are from labor organizations representing federal employees (labor members). The Assistant Secretary of Labor for Occupational Safety and Health invites interested individuals to submit nominations for membership on FACOSH. DOL anticipates filling vacancies by December 2021. Sources in addition to this 
                    <E T="04">Federal Register</E>
                     Notice will be utilized in the solicitation of nominees.
                </P>
                <P>The Secretary will appoint 16 FACOSH members to staggered terms of up to three years as follows:</P>
                <P>• Eight labor representatives—three representatives for three-year terms, three representatives for two-year terms and two representatives for one-year terms; and</P>
                <P>• Eight management representatives—three representatives for three-year terms, three representatives for two-year terms and two representatives for one-year terms.</P>
                <P>FACOSH members serve at the pleasure of the Secretary and may be appointed to successive terms. FACOSH meets at least twice a year.</P>
                <P>DOL is committed to equal opportunity in the workplace and seeks broad-based and diverse FACOSH membership. Any federal agency, labor organization, or individual may nominate one or more qualified persons for membership on FACOSH. Individuals also are invited and encouraged to submit statements in support of a nominee(s).</P>
                <HD SOURCE="HD1">C. Nomination Requirements</HD>
                <P>Submission of nominations must include the following information:</P>
                <P>1. The nominee's name and contact information;</P>
                <P>2. Category of membership (management or labor) that the nominee is qualified to represent;</P>
                <P>3. The nominee's resume or curriculum vitae, including prior membership on FACOSH and other relevant organizations, associations and committees;</P>
                <P>4. A summary of the nominee's background, experience and qualifications that address the nominee's suitability to serve on FACOSH;</P>
                <P>5. Articles or other documents the nominee has authored, if any, that indicate the nominee's knowledge, experience and expertise in occupational safety and health, particularly as it pertains to the federal workforce; and</P>
                <P>6. A statement that the nominee is aware of the nomination, is willing to regularly attend and participate in FACOSH meetings, and has no apparent conflicts of interest that would preclude membership on FACOSH.</P>
                <HD SOURCE="HD1">D. Member Selection</HD>
                <P>The Secretary appoints FACOSH members based upon criteria that include the nominee's level of responsibility for occupational safety and health matters involving the federal workforce; experience and competence in occupational safety and health; and willingness and ability to regularly and fully participate in FACOSH meetings. Federal agency management nominees who serve as their agency's Designated Agency Safety and Health Official (DASHO), or have an equivalent level of responsibility within their respective federal agencies, are preferred as management members. Labor nominees who have responsibilities for federal employee occupational safety and health matters within their labor organizations are preferred as labor members.</P>
                <P>
                    Information received through the nomination process, along with other relevant sources of information, will assist the Secretary in making appointments to FACOSH. In selecting FACOSH members, the Secretary will consider individuals nominated in response to this 
                    <E T="04">Federal Register</E>
                     notice, as well as other qualified individuals. OSHA will publish a list of the new FACOSH members in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <P>OSHA will consider any nomination submitted in response to this notice for the terms that begin January 1, 2022, or shortly thereafter. In addition, OSHA will consider the nominations for any vacancy that may occur during 2022 provided the nominee remains eligible to serve on FACOSH. OSHA believes that “rolling over” nominations for future consideration will make it easier for interested individuals to submit nominations and be considered for membership on FACOSH. This process also will provide OSHA with a broad base of nominations for ensuring that FACOSH membership is fairly balanced, which the Federal Advisory Committee Act requires (5 U.S.C. App.2, Section (5)(b)(2); 41 CFR 102-3.30(c)). OSHA will continue to request nominations as vacancies occur, but nominees whose information is current and accurate will not need to resubmit a nomination.</P>
                <HD SOURCE="HD1">Authority and Signature</HD>
                <P>James S. Frederick, Acting Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice pursuant to 5 U.S.C. 7902; 5 U.S.C. App. 2; 29 U.S.C. 668; E.O. 12196 (45 FR 12629 (2/27/1980)), as amended; 41 CFR part 102-3; and Secretary of Labor's Order 08-2020 (85 FR 58393).</P>
                <SIG>
                    <P>Signed at Washington, DC.</P>
                    <NAME>James S. Frederick,</NAME>
                    <TITLE>Acting Assistant Secretary of Labor for Occupational Safety and Health.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23029 Filed 10-21-21; 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-2016-0022]</DEPDOC>
                <SUBJECT>Bay Area Compliance Laboratories Corp.: Application for Expansion of Recognition</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.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In this notice, OSHA announces the application of Bay Area Compliance Laboratories Corp., for expansion of recognition as a Nationally Recognized Testing Laboratory (NRTL) and presents the agency's preliminary finding to grant the application.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments, information, and documents in response to this notice, or requests for an extension of time to make a submission, on or before November 8, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Comments may be submitted as follows:</P>
                    <P>
                        <E T="03">Electronically:</E>
                         You may submit comments, including attachments, electronically at 
                        <E T="03">http://www.regulations.gov,</E>
                         the Federal 
                        <PRTPAGE P="58695"/>
                        eRulemaking Portal. Follow the online instructions for submitting comments.
                    </P>
                    <P>
                        <E T="03">Facsimile:</E>
                         If your comments, including attachments, are not longer than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-1648.
                    </P>
                    <P>
                        <E T="03">Mail, hand delivery, express mail, messenger, or courier service:</E>
                         When using this method, you must submit a copy of your comments and attachments to the OSHA Docket Office, Docket No. OSHA-2016-0022, Occupational Safety and Health Administration, U.S. Department of Labor, Room N-3653, 200 Constitution Avenue NW, Washington, DC 20210. Deliveries, (hand, express mail, messenger, and courier service) are accepted during the Docket Office's normal business hours, 10:00 a.m. to 3:00 p.m., ET. 
                        <E T="03">Please note:</E>
                         While OSHA's docket office is continuing to accept and process submissions by regular mail, due to the COVID-19 pandemic, the Docket Office is closed to the public and not able to receive submissions to the rulemaking record by express delivery, hand delivery, and messenger service.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions must include the agency name and the OSHA docket number (OSHA-2016-0022). OSHA places comments and other materials, including any personal information, in the public docket without revision, and these materials will be available online at 
                        <E T="03">http://www.regulations.gov.</E>
                         Therefore, the agency cautions commenters about submitting statements they do not want made available to the public, or submitting comments that contain personal information (either about themselves or others) such as Social Security numbers, birth dates, and medical data.
                    </P>
                    <P>
                        <E T="03">Docket:</E>
                         To read or download comments or other material in the docket, go to 
                        <E T="03">https://www.regulations.gov</E>
                         or the OSHA Docket Office at the above address. All documents in the docket (including this 
                        <E T="04">Federal Register</E>
                         notice) are listed in the 
                        <E T="03">https://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.
                    </P>
                    <P>
                        <E T="03">Extension of comment period:</E>
                         Submit requests for an extension of the comment period on or before November 8, 2021 to the Office of Technical Programs and Coordination Activities, Directorate of Technical Support and Emergency Management, Occupational Safety and Health Administration, U.S. Department of Labor, 200 Constitution Avenue NW, Room N-3653, Washington, DC 20210, or by fax to (202) 693-1644.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Information regarding this notice is available from the following sources:</P>
                    <P>
                        <E T="03">Press inquiries:</E>
                         Contact Mr. Frank Meilinger, Director, OSHA Office of Communications, U.S. Department of Labor, telephone: (202) 693-1999; email: 
                        <E T="03">meilinger.francis2@dol.gov.</E>
                    </P>
                    <P>
                        <E T="03">General and technical information:</E>
                         Contact Mr. Kevin Robinson, Director, Office of Technical Programs and Coordination Activities, Directorate of Technical Support and Emergency Management, Occupational Safety and Health Administration, U.S. Department of Labor, phone: (202) 693-2110 or email: 
                        <E T="03">robinson.kevin@dol.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Notice of the Application for Expansion</HD>
                <P>OSHA is providing notice that Bay Area Compliance Laboratories Corp. (BACL) is applying for expansion of recognition as a NRTL. BACL requests the addition of seven test standards to the NRTL scope of recognition.</P>
                <P>OSHA recognition of a NRTL signifies that the organization meets the requirements specified in 29 CFR 1910.7. Recognition is an acknowledgment that the organization can perform independent safety testing and certification of the specific products covered within the scope of recognition. Each NRTL's scope of recognition includes (1) the type of products the NRTL may test, with each type specified by the applicable test standard; and (2) the recognized site(s) that has/have the technical capability to perform the product-testing and product-certification activities for test standards within the NRTL's scope. Recognition is not a delegation or grant of government authority; however, recognition enables employers to use products approved by the NRTL to meet OSHA standards that require product testing and certification.</P>
                <P>
                    The agency processes applications by a NRTL for initial recognition and for an expansion or renewal of this recognition, following requirements in Appendix A to 29 CFR 1910.7. This appendix requires that the agency publish two notices in the 
                    <E T="04">Federal Register</E>
                     in processing an application. In the first notice, OSHA announces the application and provides a preliminary finding. In the second notice, the agency provides the final decision on the application. These notices set forth the NRTL's scope of recognition or modifications of that scope. OSHA maintains an informational web page for each NRTL, including BACL, which details the NRTL's scope of recognition. These pages are available from the OSHA website at 
                    <E T="03">http://www.osha.gov/dts/otpca/nrtl/index.html.</E>
                </P>
                <P>
                    BACL currently has one facility (site) recognized by OSHA for product testing and certification, with headquarters located at: Bay Area Compliance Laboratories Corp., 1274 Anvilwood Avenue, Sunnyvale, California 94089. A complete list of BACL's scope of recognition is available at 
                    <E T="03">https://www.osha.gov/dts/otpca/nrtl/bacl.html.</E>
                </P>
                <HD SOURCE="HD1">II. General Background on the Application</HD>
                <P>BACL submitted an application, dated July 20, 2017 (OSHA-2016-0022-0009), to expand recognition to include seven additional test standards. OSHA staff performed a detailed analysis of the application packet and reviewed other pertinent information. OSHA did not perform any on-site reviews in relation to this application.</P>
                <P>Table 1 lists the appropriate test standards found in BACL's application to expand for testing and certification of products under the NRTL Program.</P>
                <GPOTABLE COLS="2" OPTS="L2,nj,p7,7/8,i1" CDEF="xs36,r25">
                    <TTITLE>Table 1—Proposed List Appropriate Test Standards for Inclusion in BACL's NRTL Scope of Recognition</TTITLE>
                    <BOXHD>
                        <CHED H="1">
                            Test
                            <LI>standard</LI>
                        </CHED>
                        <CHED H="1">Test standard title</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">UL 153</ENT>
                        <ENT>Portable Electric Luminaires.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UL 935</ENT>
                        <ENT>Standard for Fluorescent-Lamp Ballasts.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UL 1310</ENT>
                        <ENT>Standard for Class 2 Power Units.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UL 1598</ENT>
                        <ENT>Luminaires.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UL 1598C</ENT>
                        <ENT>Standard for Light Emitting Diode (LED) Retrofit Luminaire Conversion Kits.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UL 1993</ENT>
                        <ENT>Self-Ballasted Lamps and Lamp Adapters.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UL 8750</ENT>
                        <ENT>Standard for Light Emitting Diode (LED) Equipment for Use in Lighting Products.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">III. Preliminary Findings on the Application</HD>
                <P>BACL submitted an acceptable application for expansion of the scope of recognition. OSHA's review of the application file and pertinent documentation indicates BACL can meet the requirements prescribed by 29 CFR 1910.7 for expanding recognition to include the addition of these seven test standards for NRTL testing and certification in Table 1. This preliminary finding does not constitute an interim or temporary approval of BACL's application.</P>
                <P>
                    OSHA welcomes public comment as to whether BACL meets the requirements of 29 CFR 1910.7 for expansion of recognition as a NRTL. 
                    <PRTPAGE P="58696"/>
                    Comments should consist of pertinent written documents and exhibits. Commenters needing more time to comment must submit a request in writing, stating the reasons for the request. Commenters must submit the written request for an extension by the due date for comments. OSHA will limit any extension to 10 days unless the requester justifies a longer period. OSHA may deny a request for an extension if the request is not adequately justified. To obtain or review copies of the exhibits identified in this notice, as well as comments submitted to the docket, contact the Docket Office, Occupational Safety and Health Administration, U.S. Department of Labor. These materials also are available online at 
                    <E T="03">http://www.regulations.gov</E>
                     under Docket No. OSHA-2016-0022.
                </P>
                <P>OSHA staff will review all comments to the docket submitted in a timely manner. After addressing the issues raised by these comments, the agency will make a recommendation to the Assistant Secretary for Occupational Safety and Health whether to grant BACL's application for expansion of the scope of recognition. The Assistant Secretary will make the final decision on granting the application. In making this decision, the Assistant Secretary may undertake other proceedings prescribed in Appendix A to 29 CFR 1910.7.</P>
                <P>
                    OSHA will publish a public notice of the final decision in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <HD SOURCE="HD1">IV. Authority and Signature</HD>
                <P>James S. Frederick, Acting Assistant Secretary of Labor for Occupational Safety and Health, 200 Constitution Avenue NW, Washington, DC 20210, authorized the preparation of this notice. Accordingly, the agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2)), Secretary of Labor's Order No. 8-2020 (85 FR 58393, Sept. 18, 2020), and 29 CFR 1910.7.</P>
                <SIG>
                    <P>Signed at Washington, DC.</P>
                    <NAME>James S. Frederick,</NAME>
                    <TITLE>Acting Assistant Secretary of Labor for Occupational Safety and Health.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23030 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-26-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Veterans' Employment and Training Service</SUBAGY>
                <SUBJECT>Agency Information Collection Activities; Comment Request: VETS' Jobs for Veterans State Grants Program Reporting</SUBJECT>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        VETS is announcing an opportunity for public comment on the proposed revision of certain information the agency collects from grant recipients. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish a 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.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Consideration will be given to all written comments received by December 21, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        A copy of this Information Collection Request (ICR) with applicable supporting documentation, including a description of the likely respondents, proposed frequency of response, and estimated total burden, may be obtained for free by contacting Rebekah Haydin by telephone at (240) 867-2302 (this is not a toll-free number) or by email at 
                        <E T="03">Haydin.Rebekah@dol.gov.</E>
                    </P>
                    <P>
                        Submit written comments about this ICR by email to: 
                        <E T="03">Haydin.Rebekah@dol.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Rebekah Haydin, by telephone at (240) 867-2302 (this is not a toll-free number) or by email at 
                        <E T="03">Haydin.Rebekah@dol.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The Department of Labor, as part of continuing efforts to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies an opportunity to comment on proposed and/or continuing collections of information before submitting them to the OMB for final approval. This program helps to ensure requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements can be properly assessed.</P>
                <P>The Department of Labor's Veterans' Employment and Training Service (VETS) administers funds for the Jobs for Veterans State Grant (JVSG) to each state, the District of Columbia, Puerto Rico, Guam, and the U.S. Virgin Islands on an annual fiscal year basis. These non-competitive, formula-driven grants are codified under Title 38, United States Code, (38 U.S.C.) Section 4102A(b)(5):</P>
                <P>“Subject to subsection (c) make available for use in each state by grant or contract such funds as may be necessary to support—(A) disabled veterans' outreach program specialists appointed under section 4103A(a)(1) of this title, (B) local veterans' employment representatives assigned under section 4104(b) of this title, and (C) the reasonable expenses of such specialists and representatives described in subparagraphs (A) and (B), respectively, for training, travel, supplies, and other business expenses . . .”</P>
                <P>VETS provides funds to states in accordance with an allocation formula required by 38 U.S.C. 4102A(c)(2)(B) and as published in regulation at Title 20, Part 1001, Subpart F of the Code of Federal Regulations (CFR). The Assistant Secretary for Veterans' Employment and Training monitors and supervises the distribution and use of those funds as required by 38 U.S.C. 4102A(b)(6). Additionally, and in accordance with 38 U.S.C. 4107(b), the Secretary reviews performance and provides an annual report to Congress that includes a characterization of the quality and character of priority of services provided to veterans (38 U.S.C. 4215 and 20 CFR 1010.320, 1010.330), efforts to coordinate with the Veterans Administration in accordance with 38 U.S.C. 4102A(b)(3) and 4109; and incentive fund usage as described in 38 U.S.C. 4112.</P>
                <P>VETS is requesting continued approval for the information collection that streamlines the annual funding request process for grantees, reports the use of grantee funds in sufficient detail to allow interim adjustments that ensure all appropriated funding is expended properly, and provides data needed for VETS' Annual Report to Congress.</P>
                <P>The forms and reports collect required programmatic and financial data from states and territories requesting and obligating grant funds. The continued use of standardized formats for collecting this information helps to ensure that requested data is provided in a uniform way, reporting burdens are minimized, the impact of collection requirements on respondents are properly assessed, collection instruments are clearly understood by respondents, and the information is easily consolidated for posting in accordance with statutory requirements.</P>
                <P>VETS is proposing the following revisions to the forms:</P>
                <P>
                    • 
                    <E T="03">
                        Add activity to budget for and report on management and 
                        <PRTPAGE P="58697"/>
                        administrative costs.
                    </E>
                     Currently, grant recipients have no appropriate way to reflect the direct-charged salaries and benefits of staff supported by the grant other than Disabled Veterans' Outreach Program (DVOP), Local Veterans' Employment Representative (LVER), and consolidated DVOP/LVER staff. By adding an “Mgmt &amp; Admin Costs” activity to the VETS-401 Budget Information Summary, VETS-402 Expenditure Detail Report, and VETS-403 Technical Performance Narrative, grantees will be able to easily budget for and report on these expenses.
                </P>
                <P>
                    • 
                    <E T="03">Remove several reporting requirements.</E>
                     On the VETS-501 Staffing Directory, VETS proposes removing the requirement to enter each staff position's office name and number, email address, intensive service coordinator designation, and program manager designation. VETS no longer needs that information. On the VETS-403 Technical Performance Narrative, VETS proposes removing the requirement to submit a Q5 spending plan since there are no special rules for spending JVSG funding in the fifth quarter (or in later quarters) as opposed to the first four quarters. All expenditures must be made in accordance with the terms and conditions of the grant, regardless of the quarter in which the expenditure occurred.
                </P>
                <P>
                    • 
                    <E T="03">Remove the subform allowing for reporting on the cash basis of accounting.</E>
                     VETS has historically allowed recipients to report financial expenditures using either the cash basis of accounting (on the VETS-402A) or the accrual basis of accounting (on the VETS-402B). To align with 2 CFR 2900.14 as well as to accommodate certain programmatic changes, VETS has determined that JVSG recipients must report using the accrual basis of accounting. The VETS-402A subform that accommodates the cash basis will be discontinued. The VETS-402B subform will simply be referred to as the VETS-402 form since there will be no subforms.
                </P>
                <P>
                    • 
                    <E T="03">Reorganize the VETS-401 Budget Information Summary for clarity.</E>
                     VETS proposes to remove certain parts of Section B into a new section of the form, which will become Section D. The removed components include the number of full-time equivalents to be supported by each activity's allocation and the automatically-calculated salary and benefits to total expense ratio and cost per position. The reorganization will also include transposing Section C's rows and columns so that it is easier for users to compare entries with Section B. Certain row header names will be adjusted for clarity (
                    <E T="03">e.g.,</E>
                     changing “PS+PB/Total ratio” to “Salaries + Benefits/Total Percentage”) and for alignment with the SF-425 object class categories (
                    <E T="03">e.g.,</E>
                     changing “Personnel Benefits” to “Fringe Benefits”). Where appropriate, the renaming described on the VETS-401 will also be reflected on the VETS-402 and VETS-403.
                </P>
                <P>
                    • 
                    <E T="03">Formatting and structural changes to make forms compliant with Section 508 accessibility requirements.</E>
                     VETS is committed to ensuring the forms can be read by accessibility software to the greatest possible extent. Some changes to the format and appearance of the forms will be made for this purpose.
                </P>
                <P>VETS continues to require the submittal of a quarterly manager's report in accordance with 38 U.S. Code 4104(f) and Veterans' Program Letter 07-19, but the required information may be submitted in any format.</P>
                <P>With respect to the continuation of the approved collection of information, VETS is particularly interested in comments on these topics:</P>
                <P>(1) Whether the continued collection of information is necessary for the proper performance and oversight of the Jobs for Veterans State Grant, including whether the information will have practical utility;</P>
                <P>(2) The accuracy of the VETS' estimate of the burden of the proposed collection of information;</P>
                <P>(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and</P>
                <P>(4) Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.</P>
                <P>This information collection is subject to the Paperwork Reduction Act (PRA). A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number. See 5 CFR 1320.5(a) and 1320.6.</P>
                <P>The DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an Information Collection Review cannot be for more than three (3) years without renewal. The DOL notes that currently approved information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review.</P>
                <P>
                    <E T="03">Agency:</E>
                     DOL-VETS.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Revision.
                </P>
                <P>
                    <E T="03">Title of Collection:</E>
                     VETS' Jobs for Veterans State Grant Program Reporting.
                </P>
                <P>
                    <E T="03">Forms:</E>
                </P>
                <P>1. VETS-401, JVSG Budget Information Summary;</P>
                <P>2. VETS-402, JVSG Expenditure Detail Report (EDR);</P>
                <P>3. VETS-403, JVSG Technical Performance Narrative (TPN);</P>
                <P>4. VETS-501, JVSG Staffing Directory.</P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1293-0009.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     State, Local, and Tribal Governments.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     54.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Responses:</E>
                     3,402.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     6,062.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Other Cost Burden:</E>
                     $0.
                </P>
                <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s50,12,12,12,12,12">
                    <TTITLE>Estimated Annual Burden Hours</TTITLE>
                    <BOXHD>
                        <CHED H="1">
                            Type of instrument
                            <LI>(form/activity)</LI>
                        </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">
                            Total
                            <LI>number of</LI>
                            <LI>responses</LI>
                        </CHED>
                        <CHED H="1">
                            Average
                            <LI>burden time</LI>
                            <LI>per response</LI>
                            <LI>(hours)</LI>
                        </CHED>
                        <CHED H="1">
                            Estimated
                            <LI>burden hours</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">VETS-401 Budget</ENT>
                        <ENT>54</ENT>
                        <ENT>1</ENT>
                        <ENT>54</ENT>
                        <ENT>1.5</ENT>
                        <ENT>81</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">VETS-402 EDR</ENT>
                        <ENT>54</ENT>
                        <ENT>
                            <SU>1</SU>
                             6
                        </ENT>
                        <ENT>324</ENT>
                        <ENT>2</ENT>
                        <ENT>648</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">VETS-403 TPN</ENT>
                        <ENT>54</ENT>
                        <ENT>4</ENT>
                        <ENT>216</ENT>
                        <ENT>2</ENT>
                        <ENT>432</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">VETS-501 Staffing</ENT>
                        <ENT>54</ENT>
                        <ENT>1</ENT>
                        <ENT>54</ENT>
                        <ENT>1.5</ENT>
                        <ENT>81</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="01">
                            Managers Report 
                            <SU>2</SU>
                        </ENT>
                        <ENT>54</ENT>
                        <ENT>51</ENT>
                        <ENT>2,754</ENT>
                        <ENT>1.75</ENT>
                        <ENT>4,819</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="58698"/>
                        <ENT I="03">Unduplicated Total</ENT>
                        <ENT>54</ENT>
                        <ENT>118</ENT>
                        <ENT>3,402</ENT>
                        <ENT>9</ENT>
                        <ENT>6,062</ENT>
                    </ROW>
                    <TNOTE>
                        <SU>1</SU>
                         The VETS-402 EDR is a workbook that is updated on a quarterly basis until all funds are expended or the period of performance has ended. On average, grantees need six quarters to expend each year's funding.
                    </TNOTE>
                    <TNOTE>
                        <SU>2</SU>
                         Managers Reports are submitted by a number of respondents and requires a time commitment that is determined largely by grantees' discretion. Values on this row reflect actual estimates rather than VETS requirements.
                    </TNOTE>
                </GPOTABLE>
                <P>
                    <E T="03">Authority:</E>
                     44 U.S.C. 3506(c)(2)(A).
                </P>
                <SIG>
                    <P>Signed in Washington.</P>
                    <NAME>James Rodriguez,</NAME>
                    <TITLE>Acting Assistant Secretary, Veterans' Employment and Training Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23028 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-79-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">NATIONAL SCIENCE FOUNDATION</AGENCY>
                <SUBJECT>Notice of Permit Modification Received Under the Antarctic Conservation Act of 1978</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Science Foundation.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of permit modification request received and permit issued.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The National Science Foundation (NSF) is required to publish a notice of requests to modify permits issued to conduct activities regulated under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act in the Code of Federal Regulations. This is the required notice of a requested permit modification issued.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>November 2, 2017-March 30, 2020.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Polly Penhale, ACA Permit Officer, Office of Polar Programs, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, VA 22314; 703-292-7420; email: 
                        <E T="03">ACApermits@nsf.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The National Science Foundation (NSF), as directed by the Antarctic Conservation Act of 1978 (Pub. L. 95-541, 45 CFR 671), as amended by the Antarctic Science, Tourism and Conservation Act of 1996, has developed regulations for the establishment of a permit system for various activities in Antarctica and designation of certain animals and certain geographic areas as requiring special protection.</P>
                <HD SOURCE="HD1">Description of Permit Modification Requested</HD>
                <P>The Foundation issued a permit (ACA 2018-015) to Polar Latitudes Inc. on November 2, 2017. The issued permit allows the applicant to conduct waste management activities associated with coastal camping and operating remotely piloted aircraft systems (RPAS) In the Antarctic Peninsula region. Coastal overnight camping of no more than 30 campers and two expedition staff for a maximum of 10 hours ashore. Camping must be away from vegetated sites and at least 150 meters from wildlife concentrations or lakes, protected areas, historical sites, and scientific stations. The permit holder engages experienced pilots to fly small, battery-operated, remotely controlled quadcopter equipped with cameras to capture aerial footage for commercial and educational uses. The permit expires March 30, 2022. On September 4, 2018, Polar Latitudes provided NSF an update based on activities planned for the 2018-2019 field season. The activities were the same or similar as those detailed in the original permit. Hayley Shephard now holds the position of Director of Expedition Operations. On February 25, 2019, NSF issued a modification to allow waste management activities associated with whale tagging research aboard the MS ISLAND SKY, as part of an expedition within an expedition. On August 30, 2019, Polar Latitudes provided NSF with a permit modification request for activities planned for the 2019-2020 field season. The activities were the same or similar as those detailed in the original permit and previous modifications. On October 14, 2019, Polar Latitudes provided NSF an update on the support of whale tagging activities this season aboard the MC HEBREDIAN SKY in March 2020. On August 22, 2021, Polar Latitudes provided NSF with an update based on activities planned for the 2021-2022 field season which included slight changes in operation. For the 2021-2022 season, Polar Latitudes plans to operate the MS SEAVENTURE, which will carry 149 passengers and 15-20 expedition staff. Polar Latitudes requested that the number of individuals permitted for coastal camping activities be increased from 30 participants to 40 participants and four expedition guides, with increased equipment brought onshore to support a larger group. Polar Latitudes also updated their UAS policies, which are still in accordance with standards put forth by IATTO and the ATCM. The Environmental Officer has reviewed the modification request and has determined that the amendment is not a material change to the permit, and it will have a less than a minor or transitory impact.</P>
                <P>The permit modification was issued on October 5, 2021.</P>
                <SIG>
                    <NAME>Erika N. Davis,</NAME>
                    <TITLE>Program Specialist, Office of Polar Programs.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-22206 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7555-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">NUCLEAR REGULATORY COMMISSION</AGENCY>
                <DEPDOC>[NRC-2021-0001]</DEPDOC>
                <SUBJECT>Sunshine Act Meetings</SUBJECT>
                <PREAMHD>
                    <HD SOURCE="HED">TIME AND DATE: </HD>
                    <P>Weeks of October 25, November 1, 8, 15, 22, 29, 2021.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">PLACE: </HD>
                    <P>Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">STATUS: </HD>
                    <P>Public.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">MATTERS TO BE CONSIDERED:</HD>
                    <P/>
                </PREAMHD>
                <HD SOURCE="HD1">Week of October 25, 2021</HD>
                <HD SOURCE="HD2">Thursday, October 28, 2021</HD>
                <FP SOURCE="FP-2">10:00 a.m. Meeting with the Organization of Agreement States and the Conference of Radiation Control Program Directors (Public Meeting); (Contact: Stephen Poy: 301-415-7135)</FP>
                <P>
                    <E T="03">Additional Information:</E>
                     Due to COVID-19, there will be no physical public attendance. 
                </P>
                <P>
                    The public is invited to attend the Commission's meeting live by webcast at the Web address—
                    <E T="03">https://video.nrc.gov/.</E>
                </P>
                <HD SOURCE="HD1">Week of November 1, 2021—Tentative</HD>
                <P>
                    There are no meetings scheduled for the week of November 1, 2021.
                    <PRTPAGE P="58699"/>
                </P>
                <HD SOURCE="HD1">Week of November 8, 2021—Tentative</HD>
                <P>There are no meetings scheduled for the week of November 8, 2021.</P>
                <HD SOURCE="HD1">Week of November 15, 2021—Tentative</HD>
                <P>There are no meetings scheduled for the week of November 15, 2021.</P>
                <HD SOURCE="HD1">Week of November 22, 2021—Tentative</HD>
                <P>There are no meetings scheduled for the week of November 22, 2021.</P>
                <HD SOURCE="HD1">Week of November 29, 2021—Tentative</HD>
                <P>There are no meetings scheduled for the week of November 29, 2021.</P>
                <PREAMHD>
                    <HD SOURCE="HED">CONTACT PERSON FOR MORE INFORMATION: </HD>
                    <P>
                        For more information or to verify the status of meetings, contact Wesley Held at 301-287-3591 or via email at 
                        <E T="03">Wesley.Held@nrc.gov.</E>
                         The schedule for Commission meetings is subject to change on short notice.
                    </P>
                    <P>
                        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>
                    <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>
                    <P>
                        Members of the public may request to receive this information 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">Tyesha.Bush@nrc.gov</E>
                         or 
                        <E T="03">Betty.Thweatt@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: October 20, 2021.</DATED>
                    <P>For the Nuclear Regulatory Commission.</P>
                    <NAME>Wesley W. Held,</NAME>
                    <TITLE>Policy Coordinator, Office of the Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23247 Filed 10-20-21; 4:15 pm]</FRDOC>
            <BILCOD>BILLING CODE 7590-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">NUCLEAR REGULATORY COMMISSION</AGENCY>
                <DEPDOC>[Docket No. 50-293; NRC-2021-0191]</DEPDOC>
                <SUBJECT>Holtec Decommissioning International, LLC; Pilgrim Nuclear Power Station; Exemption From Certain Low-Level Waste Shipment Tracking Requirements</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Nuclear Regulatory Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Exemption; issuance.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The U.S. Nuclear Regulatory Commission (NRC) is issuing an exemption in response to a request dated August 30, 2021, as supplemented on September 23, 2021, from Holtec Decommissioning International, LLC (HDI), for the Pilgrim Nuclear Power Station (Pilgrim), from the requirement to investigate, trace, and report to the NRC any low-level radioactive waste shipment or part of a shipment for which acknowledgement of receipt is not received by HDI within 20 days after transfer from Pilgrim. HDI requested that this time period be extended from 20 to 45 days. HDI requested this change to avoid the administrative burden of investigating, tracing, and reporting on shipments that continue to be under requisite controls.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The exemption was issued on October 18, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Please refer to Docket ID NRC-2021-0191 when contacting the NRC about the availability of information regarding this document. You may obtain publicly available information related to this document using any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal Rulemaking Website:</E>
                         Go to 
                        <E T="03">https://www.regulations.gov</E>
                         and search for Docket ID NRC-2021-0191. Address questions about Docket IDs in 
                        <E T="03">Regulations.gov</E>
                         to Stacy Schumann; telephone: 301-415-0624; email: 
                        <E T="03">Stacy.Schumann@nrc.gov</E>
                        . For technical questions, contact the individual listed in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section of this document.
                    </P>
                    <P>
                        • 
                        <E T="03">NRC's Agencywide Documents Access and Management System (ADAMS):</E>
                         You may obtain publicly available documents online in the ADAMS Public Documents collection at 
                        <E T="03">https://www.nrc.gov/reading-rm/adams.html.</E>
                         To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to 
                        <E T="03">pdr.resource@nrc.gov.</E>
                         The ADAMS accession number for each document referenced (if it is available in ADAMS) is provided the first time that it is mentioned in this document.
                    </P>
                    <P>
                        • 
                        <E T="03">Attention:</E>
                         The PDR, where you may examine and order copies of public documents, is currently closed. You may submit your request to the PDR via email at 
                        <E T="03">pdr.resource@nrc.gov</E>
                         or call 1-800-397-4209 or 301-415-4737, between 8:00 a.m. and 4:00 p.m. (ET), Monday through Friday, except Federal holidays.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Amy M. Snyder, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-6822, email: 
                        <E T="03">Amy.Snyder@nrc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The text of the exemption is attached.</P>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <P>For the Nuclear Regulatory Commission.</P>
                    <NAME>Bruce A. Watson,</NAME>
                    <TITLE>Chief, Reactor Decommissioning Branch, Division of Decommissioning, Uranium Recovery and Waste Programs, Office of Nuclear Material Safety and Safeguards.</TITLE>
                </SIG>
                <FP>Attachment: Exemption</FP>
                <HD SOURCE="HD1">NUCLEAR REGULATORY COMMISSION</HD>
                <HD SOURCE="HD1">Docket No. 50-293</HD>
                <HD SOURCE="HD1">Holtec Decommissioning International, LLC</HD>
                <HD SOURCE="HD1">Pilgrim Nuclear Power Station</HD>
                <HD SOURCE="HD1">Exemption from Certain Low-Level Waste Shipment Tracking Requirements</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>The U.S. Nuclear Regulatory Commission (NRC, the Commission) license for Pilgrim Nuclear Power Station (Pilgrim) is Renewed Facility Operating License No. DPR-35. The current licensed decommissioning operator under this license is Holtec Decommissioning International, LLC (HDI). The Pilgrim license is subject to the rules, regulations, and orders of the NRC.</P>
                <P>Pilgrim is located on the western shore of Cape Cod Bay in the Town of Plymouth, Plymouth County, Massachusetts. The nearest large cities are Boston, Massachusetts, approximately 38 miles to the northwest and Providence, Rhode Island, approximately 44 miles to the west. The Pilgrim facility occupies approximately 140 acres.</P>
                <P>
                    Operation of Pilgrim permanently ceased on May 31, 2019 and all fuel was permanently removed from the Pilgrim reactor vessel on June 9, 2019. HDI is currently decommissioning the Pilgrim facility. Inherent to the 
                    <PRTPAGE P="58700"/>
                    decommissioning process, large volumes of low-level radioactive waste are generated. This low-level radioactive waste requires processing and disposal or disposal without processing, as appropriate. To this end, HDI will transport, by truck or by mixed mode shipments like a combination of truck and rail, low-level radioactive waste from Pilgrim to locations such as the waste disposal facility operated by Waste Control Specialists (WCS) in Andrews, Texas. The estimated license termination date for Pilgrim, except for the independent spent fuel storage installation (ISFSI), is 2027. The site restoration activities will be completed by 2027. HDI projects that all decommissioning activities will be completed by early September 2063, approximately 9 months after the removal of the last spent fuel from the Pilgrim ISFSI, which is estimated to occur by the end of December 2062.
                </P>
                <HD SOURCE="HD1">II. Request/Action</HD>
                <P>
                    By letter dated August 30, 2021 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML21242A267), as supplemented on September 23, 2021 (ADAMS Accession No. ML21266A277), HDI requested an exemption from certain requirements of title 10 of the 
                    <E T="03">Code of Federal Regulations</E>
                     (10 CFR) part 20, “Standards for Protection Against Radiation,” appendix G, “Requirements for Transfers of Low-Level Radioactive Waste Intended for Disposal at Licensed Land Disposal Facilities and Manifests,” Section III.E for shipments of low-level radioactive waste from Pilgrim. As indicated by HDI in its request, this regulation requires HDI to investigate, trace, and report to the NRC any low-level radioactive waste shipment or part of a shipment for which acknowledgement of receipt is not received by HDI within 20 days after transfer. HDI requested that this time period be extended from 20 days to 45 days for “mixed mode shipments from [Pilgrim], including combination of truck/rail shipments.”
                </P>
                <HD SOURCE="HD1">III. Discussion</HD>
                <P>The NRC's regulations at 10 CFR 20.2301, “Applications for exemptions,” allow the Commission to grant exemptions from the requirements of the regulations in 10 CFR part 20 if it determines the exemption is authorized by law and would not result in undue hazard to life or property.</P>
                <HD SOURCE="HD2">A. The Exemption Is Authorized by Law</HD>
                <P>The requested exemption from 10 CFR part 20, appendix G, section III.E would extend the receipt acknowledgment period from 20 days to 45 days before HDI would have to investigate, trace, and report on the status of a low-level radioactive waste shipment being transported from Pilgrim to a licensed low-level radioactive waste processing or land disposal facility. As stated above, 10 CFR 20.2301 allows the NRC to grant exemptions from the requirements of 10 CFR part 20 when, in part, the exemptions are authorized by law. The NRC determined that the requested exemption is permissible under the Atomic Energy Act of 1954, as amended, and other regulatory requirements. Therefore, the NRC finds that the requested exemption is authorized by law.</P>
                <HD SOURCE="HD2">B. The Exemption Would Not Result in Undue Hazard to Life or Property</HD>
                <P>As stated in Enclosure 1 to SECY-18-0055, “Proposed Rule: Regulatory Improvements for Production and Utilization Facilities Transitioning to Decommissioning” (ADAMS Package Accession No. ML18012A019), the underlying purpose of 10 CFR part 20, appendix G, section III.E is to require licensees to investigate, trace, and report on low-level radioactive waste shipments that have not reached their destination, as scheduled, for unknown reasons.</P>
                <P>In its exemption request, HDI stated that in May and June 2021, it had shipped numerous freight containers of low-level radioactive waste that were transloaded onto railcars for transport to the WCS disposal facility in Andrews, Texas. The total time from release of these shipments to verification of receipt varied from 22 to 56 days. HDI investigated these shipments and submitted reports on them to the NRC Region I Administrator (ADAMS Accession Nos. ML21165A399, ML21187A200, and ML21203A313).</P>
                <P>
                    In support of its exemption request, HDI identified the NRC staff statement in Enclosure 1 to SECY-18-0055 that “operating experience indicates that, while the 20-day receipt notification window is adequate for waste shipments by truck, other modes of shipment such as rail, barge, or mixed-mode shipments, such as combinations of truck and rail, barge and rail, and barge and truck shipments, may take more than 20 days to reach their destination due to delays in the route that are outside the shipper's control (
                    <E T="03">e.g.,</E>
                     rail cars in switchyards waiting to be included in a complete train to the disposal facility).” On this basis, the NRC staff proposed to amend 10 CFR part 20, appendix G, section III.E to extend the receipt notification window to 45 days. HDI also stated that its exemption request is similar to those previously submitted to and approved by the NRC for San Onofre Nuclear Generating Station, Fort Calhoun Station, and Vermont Yankee Nuclear Power Station (ADAMS Accession Nos. ML20287A358, ML20162A155, and ML20017A069, respectively).
                </P>
                <P>HDI further stated that although it takes actions during the preparation of shipments to predict and mitigate undesirable conditions, encountered delays can often extend the shipping duration beyond the 20-day requirement. According to HDI, exceeding the 20-day requirement results in the administrative burden of investigating and reporting, even though the shipments continue to be under requisite controls.</P>
                <P>
                    HDI explained that because there is not direct rail access at Pilgrim, the disposal of Pilgrim low-level radioactive waste utilizes road shipments to intermodal transfer terminals for transfer of containers onto rail as the primary transport method. According to HDI, these truck to rail shipments may sit on the rail spur at a remote railyard (
                    <E T="03">e.g.,</E>
                     waiting for a train to depart or allow for railcar repair), which may add to shipping delays. In addition, HDI believes that administrative processes at the disposal facility and communication of receipt times could add several additional days to shipping delays. Therefore, HDI concludes that receipt notifications for low-level radioactive waste shipments from Pilgrim to a waste disposal facility can often take longer than 20 days. This delay, though, is not indicative of loss, but a consequence of the complexity involved in shipping.
                </P>
                <P>The NRC staff notes that the shipments are compliant with the Department of Transportation and NRC requirements for low-level radioactive waste packaging, placarding, and radiation levels for health and safety purposes during transit, including during switchyard staging. Therefore, there are no potential health or safety concerns associated with these shipments sitting in a switchyard for an extended period of time or taking more than 20 days overall.</P>
                <P>
                    Based on the history of low-level radioactive waste shipments from Pilgrim and the lack of potential health or safety concerns associated with these shipments sitting in a switchyard for an extended period of time or taking more than 20 days overall, the need to investigate, trace, and report on these shipments that take longer than 20 days but not longer than 45 days is inappropriate. The NRC staff believes that the application of 45 days as an 
                    <PRTPAGE P="58701"/>
                    upper bound is appropriate for the same reasons as presented in Enclosure 1 to SECY-18-0055.
                </P>
                <P>Additionally, as indicated in the exemption request, for truck and rail shipments from Pilgrim, HDI will use a tracking system that allows daily monitoring of a shipment's progress to its destination and Pilgrim shipping procedures prescribe the expectations for tracking and communications during transit. The NRC staff notes that this will allow for monitoring the progress of shipments on a daily basis, if needed, in lieu of the 20-day requirement, and will initiate an investigation as provided for by 10 CFR part 20, appendix G, section III.E after 45 days. Because of this oversight and the ability to monitor low-level radioactive waste shipments throughout the entire journey from Pilgrim to a disposal or processing facility, the staff concludes that it is unlikely that a shipment could be lost, misdirected, or diverted without the knowledge of the carrier or HDI and that, therefore, there is no potential health or safety concern presented by the requested exemption. Furthermore, by extending the time for receipt acknowledgment to 45 days before requiring investigations, tracing, and reporting, a reasonable upper limit on shipment duration is maintained in the event that a breakdown of normal tracking systems were to occur.</P>
                <P>Based on the above, the NRC staff finds that the requested exemption would not result in undue hazard to life or property.</P>
                <HD SOURCE="HD2">C. Environmental Considerations</HD>
                <P>With respect to compliance with section 102(2) of the National Environmental Policy Act of 1969, as amended (NEPA), the NRC staff has determined that the proposed action, the approval of the HDI exemption request, is within the scope of the categorical exclusion at 10 CFR 51.22(c)(25). The proposed granting of the exemption from certain requirements of the NRC's regulations at 10 CFR part 20, appendix G, section III.E, would: (i) Present no significant hazards consideration; (ii) not result in a significant change in the types or significant increase in the amounts of any effluents that may be released offsite; (iii) not result in a significant increase in individual or cumulative public or occupational radiation exposure; (iv) have no significant construction impact; and (v) not result in a significant increase in the potential for or consequences from radiological accidents. Additionally, the requirements from which the exemption is sought involve reporting requirements under 10 CFR 51.22(c)(25)(vi)(B) and inspection or surveillance requirements under 10 CFR 51.22(c)(25)(vi)(C). Given the applicability of a relevant categorical exclusion, no further analysis is required under NEPA.</P>
                <HD SOURCE="HD1">IV. Conclusions</HD>
                <P>Accordingly, the Commission has determined that, pursuant to 10 CFR 20.2301, the exemption is authorized by law and will not result in undue hazard to life or property. Therefore, effective immediately, the Commission hereby grants HDI an exemption from 10 CFR part 20, appendix G, section III.E, to extend the receipt of notification period from 20 days to 45 days after transfer for rail or mixed-mode shipments of low-level radioactive waste from Pilgrim to a licensed land disposal or processing facility.</P>
                <SIG>
                    <P>Dated: October 18, 2021.</P>
                    <P>For the Nuclear Regulatory Commission.</P>
                    <P>/RA/</P>
                    <FP>Patricia K. Holahan, </FP>
                    <TITLE>Director, Division of Decommissioning, Uranium Recovery and Waste Programs, Office of Nuclear Material Safety and Safeguards.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23088 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7590-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">NUCLEAR REGULATORY COMMISSION</AGENCY>
                <DEPDOC>[Docket Nos. 50-335 and 50-389; NRC-2021-0197]</DEPDOC>
                <SUBJECT>Notice of Intent To Conduct Scoping Process and Prepare Environmental Impact Statement; Florida Power &amp; Light Co.; St. Lucie Plant Units 1 and 2</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Nuclear Regulatory Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Intent to conduct scoping process and prepare environmental impact statement; public scoping meeting and request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The U.S. Nuclear Regulatory Commission (NRC) will conduct a scoping process to gather information necessary to prepare an environmental impact statement (EIS) to evaluate the environmental impacts for the subsequent license renewal (SLR) of the operating licenses for St. Lucie Plant, Units 1 and 2 (SLP). The NRC is seeking public comment on this action and has scheduled public scoping meetings that will take place as online webinars.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The NRC will hold public scoping meetings as online webinars on November 3, 2021, from 1:00 p.m. to 3:00 p.m. and 6:00 p.m. to 8:00 p.m. Eastern Time (ET). Submit comments on the scope of the EIS by November 22, 2021. Comments received after this date will be considered if it is practical to do so, but the NRC is able to ensure consideration only for comments received on or before this date.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments by any of the following methods; however, the NRC encourages electronic comment submission through the Federal Rulemaking website:</P>
                    <P>
                        • 
                        <E T="03">Federal Rulemaking website:</E>
                         Go to 
                        <E T="03">https://regulations.gov</E>
                         and search for Docket ID NRC-2021-0197. Address questions about Docket IDs in 
                        <E T="03">Regulations.gov</E>
                         to Stacy Schumann; telephone: 301-415-0624; email: 
                        <E T="03">Stacy.Schumann@nrc.gov.</E>
                         For technical questions, contact the individual listed in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section of this document.
                    </P>
                    <P>
                        • 
                        <E T="03">Email:</E>
                         Comments may be submitted to the NRC electronically using the email address 
                        <E T="03">SaintLucieEnvironmental@nrc.gov.</E>
                    </P>
                    <P>
                        • 
                        <E T="03">Mail comments to:</E>
                         Office of Administration, Mail Stop: TWFN-7-A60M, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Program Management, Announcements and Editing Staff.
                    </P>
                    <P>
                        For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section of this document.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Lance Rakovan, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2589, email: 
                        <E T="03">Lance.Rakovan@nrc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Obtaining Information and Submitting Comments</HD>
                <HD SOURCE="HD2">A. Obtaining Information</HD>
                <P>Please refer to Docket ID NRC-2021-0197 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:</P>
                <P>
                    • 
                    <E T="03">Federal Rulemaking Website:</E>
                     Go to 
                    <E T="03">https://regulations.gov</E>
                     and search for Docket ID NRC-2021-0197.
                </P>
                <P>
                    • 
                    <E T="03">NRC's Agencywide Documents Access and Management System (ADAMS):</E>
                     You may obtain publicly available documents online in the ADAMS Public Documents collection at 
                    <E T="03">https://www.nrc.gov/reading-rm/adams.html.</E>
                     To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact 
                    <PRTPAGE P="58702"/>
                    the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to 
                    <E T="03">pdr.resource@nrc.gov.</E>
                     The ADAMS accession number for each document referenced in this document (if it is available in ADAMS) is provided the first time that it is referenced.
                </P>
                <P>
                    • 
                    <E T="03">Attention:</E>
                     The PDR, where you may examine and order copies of public documents, is currently closed. You may submit your request to the PDR via email at 
                    <E T="03">pdr.resource@nrc.gov</E>
                     or call 1-800-397-4209 or 301-415-4737, between 8:00 a.m. and 4:00 p.m. ET, Monday through Friday, except Federal holidays.
                </P>
                <P>
                    • 
                    <E T="03">Public Library:</E>
                     A copy of the SLR application, including the environmental report (ER), is available for public review at the following public library locations:
                </P>
                <P>• Morningside Branch of the St. Lucie County Library, 2410 SE Morningside Blvd., Port St. Lucie, FL 4952; and</P>
                <P>• Kilmer Branch of the St. Lucie County Library, 101 Melody Lane, Fort Pierce, FL 34950.</P>
                <HD SOURCE="HD2">B. Submitting Comments</HD>
                <P>
                    The NRC encourages electronic comment submission through the Federal Rulemaking website (
                    <E T="03">https://www.regulations.gov</E>
                    ). Please include Docket ID NRC-2021-0197 in the subject line of your comment submission in order to ensure that the NRC is able to make your comment submission available to the public in this docket.
                </P>
                <P>
                    The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at 
                    <E T="03">https://www.regulations.gov</E>
                     as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.
                </P>
                <P>If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.</P>
                <HD SOURCE="HD1">II. Discussion</HD>
                <P>
                    By letter dated August 3, 2021 (ADAMS Package Accession No. ML21215A314), Florida Power &amp; Light Co. (FPL) submitted to the NRC an application for subsequent license renewal of Renewed Facility Operating License Nos. DPR-67 and NPR-16 for SLP, Units 1 and 2, respectively, for an additional 20 years of operation. This submission initiated the NRC's proposed action of determining whether to grant the SLR application. The SLP units are pressurized water reactors designed by Combustion Engineering and are located in Jensen Beach, FL, approximately 10 miles southeast of Ft. Pierce, FL. The current renewed facility operating license for Unit 1 expires at midnight on March 1, 2036, and the current renewed facility operating license for Unit 2 expires at midnight on April 6, 2043. The SLR application was submitted pursuant to part 54 of title 10 of the 
                    <E T="03">Code of Federal Regulations</E>
                     (10 CFR), “Requirements for Renewal of Operating Licenses for Nuclear Power Plants,” and seeks to extend the renewed facility operating license for Unit 1 to midnight on March 1, 2056, and the renewed facility operating license for Unit 2 to midnight on April 6, 2063. A notice of receipt and availability of the application was published in the 
                    <E T="04">Federal Register</E>
                     on August 16, 2021 (86 FR 45768). A notice of acceptance for docketing of the application and of opportunity to request a hearing was published in the 
                    <E T="04">Federal Register</E>
                     on September 29, 2021 (86 FR 53986) and is available on the Federal Rulemaking website (
                    <E T="03">https://www.regulations.gov</E>
                    ) by searching for Docket ID NRC-2021-0197.
                </P>
                <HD SOURCE="HD1">III. Request for Comment</HD>
                <P>This notice informs the public of the NRC's intention to conduct environmental scoping and prepare an EIS related to the SLR application for SLP, and to provide the public an opportunity to participate in the environmental scoping process, as defined in 10 CFR 51.29, “Scoping-environmental impact statement and supplement to environmental impact statement.”</P>
                <P>
                    The regulations in 36 CFR 800.8, “Coordination With the National Environmental Policy Act,” allow agencies to use their National Environmental Policy Act of 1969 (42 U.S.C. 4321, 
                    <E T="03">et seq.</E>
                    ) (NEPA) process to fulfill the requirements of Section 106 of the National Historic Preservation Act of 1966 (54 U.S.C. 300101, 
                    <E T="03">et seq.</E>
                    ) (NHPA). Therefore, pursuant to 36 CFR 800.8(c), the NRC intends to use its process and documentation required for the preparation of the EIS on the proposed action to comply with Section 106 of the NHPA in lieu of the procedures set forth at 36 CFR 800.3 through 800.6.
                </P>
                <P>
                    In accordance with 10 CFR 51.53(c) and 10 CFR 54.23, FPL submitted an ER as part of the SLR application. The ER was prepared pursuant to 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions,” and is publicly available in ADAMS under Package Accession No. ML21215A314. The ER will also be available for viewing at 
                    <E T="03">https://www.nrc.gov/reactors/operating/licensing/renewal/subsequent-license-renewal.html.</E>
                     In addition, the SLR application, including the ER, is available for public review at the Morningside Branch of the St. Lucie County Library, 2410 SE Morningside Blvd., Port St. Lucie, FL 4952, and the Kilmer Branch of the St. Lucie County Library, 101 Melody Lane, Fort Pierce, FL 34950.
                </P>
                <P>The NRC intends to gather the information necessary to prepare a plant-specific supplement to NUREG-1437, “Generic Environmental Impact Statement for License Renewal of Nuclear Plants” (ADAMS Package Accession No. ML13107A023) (GEIS), related to the SLR application for St. Lucie. The NRC is required by 10 CFR 51.95 to prepare a plant-specific supplement to the GEIS in connection with the renewal of an operating license. This notice is being published in accordance with NEPA and the NRC's regulations at 10 CFR part 51.</P>
                <P>The supplement to the GEIS will evaluate the environmental impacts of subsequent license renewal for SLP, and reasonable alternatives thereto. Possible alternatives to the proposed action include the no action alternative and reasonable alternative energy sources.</P>
                <P>As part of its environmental review, the NRC will first conduct a scoping process for the plant-specific supplement to the GEIS and, as soon as practicable thereafter, will prepare a draft supplement to the GEIS for public comment. Participation in this scoping process by members of the public and local, State, Tribal, and Federal government agencies is encouraged. The scoping process for the supplement to the GEIS will be used to accomplish the following:</P>
                <P>a. Define the proposed action that is to be the subject of the supplement to the GEIS;</P>
                <P>b. Determine the scope of the supplement to the GEIS and identify the significant issues to be analyzed in depth;</P>
                <P>
                    c. Identify and eliminate from detailed study those issues that are peripheral or are not significant or that have been covered by prior environmental review;
                    <PRTPAGE P="58703"/>
                </P>
                <P>d. Identify any environmental assessments and other ElSs that are being or will be prepared that are related to, but are not part of, the scope of the supplement to the GEIS under consideration;</P>
                <P>e. Identify other environmental review and consultation requirements related to the proposed action;</P>
                <P>f. Indicate the relationship between the timing of the preparation of the environmental analyses and the NRC's tentative planning and decision-making schedule;</P>
                <P>g. Identify any cooperating agencies and, as appropriate, allocate assignments for preparation and schedules for completing the supplement to the GEIS to the NRC and any cooperating agencies; and</P>
                <P>h. Describe how the supplement to the GEIS will be prepared, including any contractor assistance to be used.</P>
                <P>The NRC invites the following entities to participate in scoping:</P>
                <P>a. The applicant, Florida Power &amp; Light;</P>
                <P>b. Any Federal agency that has jurisdiction by law or special expertise with respect to any environmental impact involved or that is authorized to develop and enforce relevant environmental standards;</P>
                <P>c. Affected State and local government agencies, including those authorized to develop and enforce relevant environmental standards;</P>
                <P>d. Any affected Indian Tribe;</P>
                <P>e. Any person who requests or has requested an opportunity to participate in the scoping process; and</P>
                <P>f. Any person who has petitioned or intends to petition for leave to intervene under 10 CFR 2.309.</P>
                <HD SOURCE="HD1">IV. Public Scoping Meeting</HD>
                <P>In accordance with 10 CFR 51.26(b), the scoping process for an EIS may include a public scoping meeting to help identify significant issues related to the proposed action and to determine the scope of issues to be addressed in the EIS.</P>
                <P>
                    The NRC is announcing that it will hold public scoping meetings as online webinars for the SLP SLR supplement to the GEIS. The webinars will include a telephone line for members of the public to provide comments. A court reporter will transcribe all comments received during the webinars. To be considered, comments must be provided either at a transcribed public meeting or in writing, as discussed in the 
                    <E T="02">ADDRESSES</E>
                     section of this notice. The public scoping webinars will be held on November 3, 2021, from 1:00 p.m. to 3:00 p.m. and from 6:00 p.m. to 8:00 p.m. ET. Persons interested in attending these online webinars should monitor the NRC's Public Meeting Schedule website at 
                    <E T="03">https://www.nrc.gov/pmns/mtg</E>
                     for additional information, agenda for the meeting, and access information for the webinar. Please contact Mr. Lance Rakovan no later than October 27, 2021, if accommodations or special equipment is needed to attend or to provide comments, so that the NRC staff can determine whether the request can be accommodated.
                </P>
                <P>The public scoping meeting will include: (1) An overview by the NRC staff of the environmental and safety review processes, the proposed scope of the supplement to the GEIS, and the proposed review schedule; and (2) the opportunity for interested government agencies, organizations, and individuals to submit comments or suggestions on environmental issues or the proposed scope of the SLP SLR supplement to the GEIS.</P>
                <P>Participation in the scoping process for the SLP SLR supplement to the GEIS does not entitle participants to become parties to the proceeding to which the supplement to the GEIS relates. Matters related to participation in any hearing are outside the scope of matters to be discussed at this public meeting.</P>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <P>For the Nuclear Regulatory Commission.</P>
                    <NAME>Robert B. Elliott,</NAME>
                    <TITLE>Chief, Environmental Review License Renewal Branch, Division of Rulemaking, Environment, and Financial Support, Office of Nuclear Material Safety and Safeguards.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23073 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7590-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">NUCLEAR REGULATORY COMMISSION</AGENCY>
                <DEPDOC>[Docket Nos. 50-269-SLR, 50-270-SLR, and 50-287-SLR; ASLBP No. 22-973-01-SLR-BD01]</DEPDOC>
                <SUBJECT>
                    Duke Energy Carolinas, LLC; Establishment of Atomic Safety and Licensing Board 
                    <SU>1</SU>
                    <FTREF/>
                </SUBJECT>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         This issuance, which supersedes the Board Establishment Notice issued on October 4, 2021, contains the following corrected ASLBP docket number: ASLBP No. 22-973-01-SLR-BD01.
                    </P>
                </FTNT>
                <P>
                    Pursuant to delegation by the Commission, 
                    <E T="03">see</E>
                     37 FR 28,710 (Dec. 29, 1972), and the Commission's regulations, 
                    <E T="03">see, e.g.,</E>
                     10 CFR 2.104, 2.105, 2.300, 2.309, 2.313, 2.318, 2.321, notice is hereby given that an Atomic Safety and Licensing Board (Board) is being established to preside over the following proceeding:
                </P>
                <FP SOURCE="FP-1">DUKE ENERGY CAROLINAS, LLC, (Oconee Nuclear Station, Units 1, 2, and 3)</FP>
                <P>
                    This proceeding involves an application seeking a twenty-year subsequent license renewal of Renewed Facility Operating License Nos. DPR-38, DPR-47, and DPR-55, which authorize Duke Energy Carolinas, LLC to operate the Oconee Nuclear Station, Units 1, 2, and 3, located in Seneca, South Carolina until, respectively, February 6, 2033, October 6, 2033, and July 19, 2034. In response to a notice published in the 
                    <E T="04">Federal Register</E>
                     announcing the opportunity to request a hearing, 
                    <E T="03">see</E>
                     86 FR 40,662 (July 28, 2021), a hearing request was filed on September 27, 2021, on behalf of Beyond Nuclear and Sierra Club.
                </P>
                <P>The Board is comprised of the following Administrative Judges:</P>
                <FP SOURCE="FP-1">G. Paul Bollwerk, III, Chairman, Atomic Safety and Licensing Board Panel, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001</FP>
                <FP SOURCE="FP-1">Nicholas G. Trikouros, Atomic Safety and Licensing Board Panel, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001</FP>
                <FP SOURCE="FP-1">Dr. Gary S. Arnold, Atomic Safety and Licensing Board Panel, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001</FP>
                <P>
                    All correspondence, documents, and other materials shall be filed in accordance with the NRC E-Filing rule. 
                    <E T="03">See</E>
                     10 CFR 2.302.
                </P>
                <SIG>
                    <P>Rockville, Maryland.</P>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>Edward R. Hawkens,</NAME>
                    <TITLE>Chief Administrative Judge, Atomic Safety and Licensing Board Panel.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23109 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7590-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">POSTAL REGULATORY COMMISSION</AGENCY>
                <DEPDOC>[Docket Nos. MC2022-11 and CP2022-12]</DEPDOC>
                <SUBJECT>New Postal Product</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>
                         October 26, 2021.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit comments electronically via the Commission's Filing Online system at 
                        <E T="03">
                            http://
                            <PRTPAGE P="58704"/>
                            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>
                     MC2022-11 and CP2022-12; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail, Parcel Select, &amp; First-Class Package Service Contract 1 to Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     October 18, 2021; 
                    <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>
                     Christopher C. Mohr; 
                    <E T="03">Comments Due:</E>
                     October 26, 2021.
                </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. 2021-23070 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-FW-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[Release No. 34-93371; File No. SR-OCC-2021-011]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; the Options Clearing Corporation; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Concerning the Interest Rates Used for Options Pricing in the STANS Methodology Description</SUBJECT>
                <DATE>October 18, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act” or “Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on October 6, 2021, the Options Clearing Corporation (“OCC”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in Items I, II, and III below, which Items have been prepared by OCC. OCC filed the proposed rule change pursuant to Section 19(b)(3)(A) 
                    <SU>3</SU>
                    <FTREF/>
                     of the Act and Rule 19b-4(f)(1) 
                    <SU>4</SU>
                    <FTREF/>
                     thereunder so that the proposal was effective upon filing with the Commission. 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>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         17 CFR 240.19b-4(f)(1).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Clearing Agency's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>
                    OCC is filing a proposed rule change to make clarifying changes to OCC's System for Theoretical Analysis and Numerical Simulation (“STANS”) Methodology Description concerning the interest rates used for options pricing. The proposed changes to OCC's STANS Methodology Description are contained in confidential Exhibit 5 of filing SR-OCC-2021-011. Material proposed to be added to the STANS Methodology Description as currently in effect is underlined and material proposed to be deleted is marked in strikethrough text. All capitalized terms not defined herein have the same meaning as set forth in the OCC By-Laws and Rules.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         OCC's By-Laws and Rules can be found on OCC's public website: 
                        <E T="03">https://www.theocc.com/Company-Information/Documents-and-Archives/By-Laws-and-Rules.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. Clearing Agency's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <P>In its filing with the Commission, OCC 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. OCC has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of these statements.</P>
                <HD SOURCE="HD2">(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <HD SOURCE="HD3">(1)  Purpose </HD>
                <HD SOURCE="HD3">Background</HD>
                <P>
                    STANS is OCC's proprietary risk management system for calculating Clearing Member margin requirements.
                    <SU>6</SU>
                    <FTREF/>
                     The STANS methodology utilizes large-scale Monte Carlo simulations to forecast price and volatility movements in determining a Clearing Member's margin requirement.
                    <SU>7</SU>
                    <FTREF/>
                     STANS margin requirements are calculated at the portfolio level of Clearing Member accounts with positions in marginable securities and consists of an estimate of two primary components: A base component and a concentration/dependence stress test add-on component. The base component is an estimate of a 99% expected
                    <FTREF/>
                     shortfall 
                    <SU>8</SU>
                      
                    <PRTPAGE P="58705"/>
                    over a two-day time horizon. The concentration/dependence stress test add-on is obtained by considering increases in the expected margin shortfall for an account that would occur due to (i) market movements that are especially large and/or in which certain risk factors would exhibit perfect or zero correlations rather than correlations otherwise estimated using historical data or (ii) extreme and adverse idiosyncratic movements for individual risk factors to which the account is particularly exposed. OCC uses the STANS methodology to measure the exposure of portfolios of options and futures cleared by OCC and cash instruments in margin collateral.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See</E>
                         Exchange Act Release No. 91079 (Feb. 8, 2021), 86 FR 9410 (Feb. 12, 2021) (File No. SR-OCC-2020-016). OCC makes its STANS Methodology description available to Clearing Members. An overview of the STANS methodology is available at 
                        <E T="03">https://www.theocc.com/Risk-Management/Margin-Methodology.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See</E>
                         OCC Rule 601.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         The expected shortfall component is established as the estimated average of potential losses higher than the 99% value at risk threshold. The term “value at risk” or “VaR” refers to a statistical 
                        <PRTPAGE/>
                        technique that, generally speaking, is used in risk management to measure the potential risk of loss for a given set of assets over a particular time horizon.
                    </P>
                </FTNT>
                <P>In the STANS methodology, the interest rate discount curve is a critical input for OCC's pricing models. OCC's pricing models are developed using the Black-Scholes framework. OCC uses the interest rate curve, which is constructed from market instruments, along with dividends, implied borrow cost, and implied volatility to specify underlying price dynamics. OCC uses this data along with exchange listed option price data to calibrate the implied borrow cost and implied volatility parameters used in the option pricing models. STANS margins are computed using models to generate 10,000 scenarios on underlying price and implied volatility, and those price and implied volatility scenarios are used as inputs to the option pricing model (along with the interest rate curve) to re-price the options. The margin base component is then determined from the profit-and-loss distribution of the scenario prices.</P>
                <P>
                    OCC currently constructs the interest rate discount curve using instruments referencing the London Interbank Offered Rate (“LIBOR”). LIBOR is a key benchmark interest rate at which major global banks lend to one another in the international interbank market for short-term loans. LIBOR is also commonly used by financial market participants more broadly to gauge prevailing interest rates; however, financial market participants are expected to largely transition away from the use of LIBOR by the end of 2021.
                    <SU>9</SU>
                    <FTREF/>
                     Accordingly, OCC intends to transition to a new benchmark rate for constructing its interest rate curve to align with this industry transition.
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">See https://www.sec.gov/news/public-statement/libor-transition.</E>
                    </P>
                </FTNT>
                <P>
                    The STANS Methodology Description currently provides a general description of OCC's method for constructing the interest rate discount curve but does not specify any particular benchmark rate.
                    <SU>10</SU>
                    <FTREF/>
                     While the STANS Methodology Description is intended to provide flexibility in the benchmark rate used, the document contains certain details of the interest rate curve construction process that more closely reflect the use of LIBOR as the benchmark rate.
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See supra</E>
                         note 6.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Proposed Changes</HD>
                <P>OCC proposes to revise its STANS Methodology Description to clean up certain details regarding the interest rate curve construction process. Section 3.2 of the STANS Methodology Description describes OCC's method for constructing the interest rate discount curve used to accurately price the options cleared by OCC. While the STANS Methodology Description does not specify the interest rate used in this process, the document contains certain details that more closely reflect the use of LIBOR as the benchmark rate. As noted above, the industry plans to transition away from using LIBOR as the benchmark for short-term interest rates by the end of 2021. OCC therefore proposes additional clarifying and clean up changes to the STANS Methodology Description so that the methodology more accurately reflects the potential use of different industry standard benchmark rates to construct the interest rate discount curve in STANS.</P>
                <HD SOURCE="HD3">(2)  Statutory Basis </HD>
                <P>
                    OCC believes the proposed rule change is consistent with Section 17A of the Act 
                    <SU>11</SU>
                    <FTREF/>
                     and the rules thereunder applicable to OCC. Section 17A(b)(3)(F) of the Act 
                    <SU>12</SU>
                    <FTREF/>
                     requires, in part, that the rules of a clearing agency be designed to promote the prompt and accurate clearance and settlement of derivative agreements, contracts, and transactions and to assure the safeguarding of securities and funds which are in its custody or control or for which it is responsible. The proposed rule change would make minor changes to the STANS Methodology Description to clarify the use of different industry benchmark interest rates used for discounting options pricing. The proposed rule change would ensure that OCC's STANS methodology documentation remains accurate and is aligned with standard industry practice after the industry transitions away from LIBOR. OCC uses the margin it collects from a defaulting Clearing Member to protect other Clearing Members from losses that may result from the default and ensure that OCC is able to continue the prompt and accurate clearance and settlement of its cleared products. Moreover, OCC believes that accurate calculation of margin requirements is necessary to help OCC manage the risk of a Clearing Member default without recourse to the assets of non-defaulting Clearing Members, which supports the safeguarding of securities and funds in OCC's custody or control. OCC believes that the proposed rule change would result in more accurate documentation for its margin methodology and is therefore consistent with the requirements of Section 17A(b)(3)(F) of the Act.
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         15 U.S.C. 78q-1.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         15 U.S.C. 78q-1(b)(3)(F).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>
                    Exchange Act Rules 17Ad-22(e)(6)(i) and (iii) 
                    <SU>14</SU>
                    <FTREF/>
                     further require that a covered clearing agency establish, implement, maintain and enforce written policies and procedures reasonably designed to cover its credit exposures to its participants by establishing a risk-based margin system that, among other things: (1) Considers, and produces margin levels commensurate with, the risks and particular attributes of each relevant product, portfolio, and market and (2) calculates margin sufficient to cover its potential future exposure to participants in the interval between the last margin collection and the close out of positions following a participant default. The proposed rule change would result in more accurate documentation for OCC's STANS margin methodology, particularly once the industry and OCC transition away from LIBOR later this year. OCC therefore believes the proposed rule change would result in more accurate policies and procedures that are reasonably designed to produce margin levels commensurate with the risks and particular attributes of its cleared options and calculate margin sufficient to cover its potential future exposure to participants in the interval between the last margin collection and the close out of positions following a participant default. In this way, OCC believes the proposed rule change is consistent with the requirements of Rules 17Ad-22(e)(6)(i) and (iii).
                    <SU>15</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         17 CFR 240.17Ad-22(e)(6)(i) and (iii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         17 CFR 240.17Ad-22(e)(6)(i) and (iii).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">(B) Clearing Agency's Statement on Burden on Competition</HD>
                <P>
                    Section 17A(b)(3)(I) of the Act 
                    <SU>16</SU>
                    <FTREF/>
                     requires that the rules of a clearing agency not impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. OCC does not believe that the proposed rule change 
                    <PRTPAGE P="58706"/>
                    would have any impact or impose a burden on competition. The proposed rule change would make clarifying and clean up changes to OCC's margin methodology concerning the industry benchmark interest rates used for discounting options pricing. OCC does not believe that the proposed rule change would unfairly inhibit access to OCC's services or disadvantage or favor any particular user in relationship to another user. OCC therefore does not believe that the proposed rule change would have any impact or impose a burden on competition.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         15 U.S.C. 78q-1(b)(3)(I).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">(C) Clearing Agency's Statement on Comments on the Proposed Rule Change Received From Members, Participants or Others</HD>
                <P>Written comments on the proposed rule change were not and are not intended to be solicited with respect to the proposed rule change and none have been received.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    Pursuant to Section 19(b)(3)(A) of the Act,
                    <SU>17</SU>
                    <FTREF/>
                     and Rule 19b-4(f)(1) thereunder,
                    <SU>18</SU>
                    <FTREF/>
                     the proposed rule change is filed for immediate effectiveness because it constitutes a stated policy, practice, or interpretation with respect to the meaning, administration, or enforcement of an existing rule.
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         17 CFR 240.19b-4(f)(1).
                    </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.
                    <SU>19</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         Notwithstanding its immediate effectiveness, implementation of this rule change will be delayed until this change is deemed certified under CFTC Rule 40.6.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">IV. Solicitation of Comments</HD>
                <P>Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:</P>
                <HD SOURCE="HD2">Electronic Comments</HD>
                <P>
                    • Use the Commission's internet comment form (
                    <E T="03">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-OCC-2021-011 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-OCC-2021-011. 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 such filing also will be available for inspection and copying at the principal office of OCC and on OCC's website at 
                    <E T="03">https://www.theocc.com/Company-Information/Documents-and-Archives/By-Laws-and-Rules.</E>
                </FP>
                <P>All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly.</P>
                <P>All submissions should refer to File Number SR-OCC-2021-011 and should be submitted on or before November 12, 2021.</P>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>20</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>20</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23021 Filed 10-21-21; 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. 34-93374; File No. SR-C2-2021-015]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Cboe C2 Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Extend the Pilot Period Related to the Market-Wide Circuit Breaker in Rule 6.32.01</SUBJECT>
                <DATE>October 18, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4  thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on October 14, 2021, Cboe C2 Exchange, Inc. (the “Exchange” or “C2”) filed with the Securities and Exchange Commission (the “Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the Exchange. The Exchange filed the proposal as a “non-controversial” proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act 
                    <SU>3</SU>
                    <FTREF/>
                     and Rule 19b-4 (f)(6) thereunder.
                    <SU>4</SU>
                    <FTREF/>
                     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>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         15 U.S.C. 78s(b)(3)(A)(iii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         17 CFR 240.19b-4 (f)(6).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>Cboe C2 Exchange, Inc. (the “Exchange” or “C2”) proposes to extend the pilot period related to the market-wide circuit breaker in Rule 6.32.01. The text of the proposed rule change is provided in Exhibit 5.</P>
                <P>
                    The text of the proposed rule change is also available on the Exchange's website (
                    <E T="03">http://markets.cboe.com/us/options/regulation/rule_filings/ctwo/</E>
                    ), at the Exchange's Office of the Secretary, and at the Commission's Public Reference Room.
                </P>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and the 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 
                    <PRTPAGE P="58707"/>
                    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>The Exchange proposes to extend the pilot related to the market-wide circuit breaker in Rule 6.32.01 to the close of business on March 18, 2022.</P>
                <HD SOURCE="HD3">Background</HD>
                <P>The Market-Wide Circuit Breaker (“MWCB”) rules, including the Exchange's Rule 6.32.01, provide an important, automatic mechanism that is invoked to promote stability and investor confidence during periods of significant stress when cash equities securities experience extreme market-wide declines. The MWCB rules are designed to slow the effects of extreme price declines through coordinated trading halts across both cash equity and equity options securities markets.</P>
                <P>
                    The cash equities rules governing MWCBs were first adopted in 1988 and, in 2012, all U.S. cash equity exchanges and FINRA amended their cash equities uniform rules on a pilot basis (the “Pilot Rules”, including Exchange Rule 6.32.01).
                    <SU>5</SU>
                    <FTREF/>
                     The Securities and Exchange Commission (the “Commission”) approved the Pilot Rules, the term of which was to coincide with the pilot period for the Plan to Address Extraordinary Market Volatility Pursuant to Rule 608 of Regulation NMS (the “LULD Plan”),
                    <SU>6</SU>
                    <FTREF/>
                     including any extensions to the pilot period for the LULD Plan. Though the LULD Plan was primarily designed for equity markets, the Exchange believed it would, indirectly, potentially impact the options markets as well. Thus, the Exchange has previously adopted and amended Rule 6.32.01 (as well as other options pilot rules) to ensure the option markets were not harmed as a result of the Plan's implementation and implemented such rule on a pilot basis that has coincided with the pilot period for the Plan.
                    <SU>7</SU>
                    <FTREF/>
                     In April 2019, the Commission approved an amendment to the LULD Plan for it to operate on a permanent, rather than pilot, basis.
                    <SU>8</SU>
                    <FTREF/>
                     In light of the proposal to make the LULD Plan permanent, the Exchange amended Rule 6.32.01 to untie the pilot's effectiveness from that of the LULD Plan and to extend the pilot's effectiveness to the close of business on October 18, 2019.
                    <SU>9</SU>
                    <FTREF/>
                     The Exchange subsequently amended Rule 6.32.01 to extend the pilot to the close of business on October 18, 2020 
                    <SU>10</SU>
                    <FTREF/>
                    , and later, on October 18, 2021.
                    <SU>11</SU>
                    <FTREF/>
                     The Exchange now proposes to amend Rule 6.32.01 to extend the pilot to the close of business on March 18, 2022. This filing does not propose any substantive or additional changes to Rule 6.32.01.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 67090 (May 31, 2012), 77 FR 33531 (June 6, 2012) (SR-BATS-2011-038; SR-BYX-2011-025; SR-BX-2011-068; SR-CBOE-2011-087; SR-C2-2011-024; SR-CHX-2011-30; SR-EDGA-2011-31; SR-EDGX-2011-30; SR-FINRA-2011-054; SR-ISE-2011-61; SR-NASDAQ-2011-131; SR-NSX-2011-11; SR-NYSE-2011-48; SRNYSEAmex-2011-73; SR-NYSEArca-2011-68; SR-Phlx-2011-129) (“Pilot Rules Approval Order”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 67091 (May 31, 2012), 77 FR 33498 (June 6, 2012). The LULD Plan provides a mechanism to address extraordinary market volatility in individual securities.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release Nos. 68769 (January 30, 2013), 78 FR 8213 (February 5, 2013) (SR-C2-2013-006) (amending Rule 6.32.03, which was later renumbered to Rule 6.32.01, to delay the operative date of the pilot to coincide with the initial date of operations of the Plan); and 85624 (April 11, 2019), 84 FR 16130 (April 17, 2019) (SR-C2-2019-008) (proposal to extend the pilot for certain options pilots, including Rule 6.32.01).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 85623 (April 11, 2019), 84 FR 16086 (April 17, 2019) (Order Approving Amendment No. 18).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 85624 (April 11, 2019), 84 FR 16130 (April 17, 2019) (SR-C2-2019-008) (proposal to extend the pilot for certain options pilots, including Rule 6.32.01).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 87342 (October 18, 2019), 84 FR 57102 (October 24, 2019) (SR-C2-2019-022).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 90158 (October 13, 2020), 85 FR 66388 (October 19, 2020) (SR-C2-2020-015).
                    </P>
                </FTNT>
                <P>As stated above, because all U.S. equity exchanges and FINRA adopted uniform Pilot Rules relating to market-wide circuit breakers in 2012, the Exchange, too, adopted a MWCB mechanism on a pilot basis pursuant to Rule 6.32.01. Pursuant to Rule 6.32.01, a market-wide trading halt will be triggered if the S&amp;P 500 Index declines in price by specified percentages from the prior day's closing price of that index. Currently, the triggers are set at three circuit breaker thresholds: 7% (Level 1), 13% (Level 2), and 20% (Level 3). A market decline that triggers a Level 1 or Level 2 halt after 9:30 a.m. ET and before 3:25 p.m. ET would halt market-wide trading for 15 minutes, while a similar market decline at or after 3:25 p.m. ET would not halt market-wide trading. A market decline that triggers a Level 3 halt, at any time during the trading day, would halt market-wide trading for the remainder of the trading day.</P>
                <HD SOURCE="HD3">The MWCB Task Force and the March 2020 MWCB Events</HD>
                <P>In late 2019, Commission staff requested the formation of a MWCB Task Force (“Task Force”) to evaluate the operation and design of the MWCB mechanism. The Task Force included representatives from the SROs, the Commission, CME, the Commodity Futures Trading Commission (“CFTC”), and the securities industry and conducted several organizational meetings in December 2019 and January 2020. In Spring 2020, the MWCB mechanism proved itself to be an effective tool for protecting markets through turbulent times. In March 2020, at the outset of the worldwide COVID-19 pandemic, U.S. equities markets experienced four MWCB Level 1 halts, on March 9, 12, 16, and 18, 2020. In each instance, the markets halted as intended upon a 7% drop in the S&amp;P 500 Index, and resumed as intended 15 minutes later.</P>
                <P>
                    In response to these events, in the Spring and Summer of 2020, the Task Force held ten meetings that were attended by Commission staff, with the goal of performing an expedited review of the March 2020 halts and identifying any areas where the MWCB mechanism had not worked properly. Given the risk of unintended consequences, the Task Force did not recommend changes that were not rooted in a noted deficiency. The Task Force recommended creating a process for a backup reference price in the event that SPX were to become unavailable, and enhancing functional MWCB testing. The Task Force also asked CME to consider modifying its rules to enter into a limit-down state in the futures pre-market after a 7% decline instead of 5%. CME made the requested change, which became effective on October 12, 2020.
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See https://www.cmegroup.com/content/dam/cmegroup/market-regulation/rulefilings/2020/9/20-392_1.pdf;</E>
                          
                        <E T="03">https://www.cmegroup.com/content/dam/cmegroup/marketregulation/rule-filings/2020/9/20-392_2.pdf.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD3">The MWCB Working Group's Study</HD>
                <P>
                    On September 17, 2020, the Director of the Commission's Division of Trading and Markets asked the SROs to conduct a more complete study of the design and operation of the Pilot Rules and the LULD Plan during the period of volatility in the Spring of 2020. In response to the request, the SROs created a MWCB “Working Group” composed of SRO representatives and industry advisers that included members of the advisory committees to both the LULD Plan and the NMS Plans governing the collection, consolidation, and dissemination of last-sale transaction reports and quotations in NMS Stocks. The Working Group met regularly from September 2020 through March 2021 to consider the 
                    <PRTPAGE P="58708"/>
                    Commission's request, review data, and compile its study. The Working Group's efforts in this respect incorporated and built on the work of an MWCB Task Force. The Working Group submitted its study to the Commission on March 31, 2021 (the “Study”).
                    <SU>13</SU>
                    <FTREF/>
                     In addition to a timeline of the MWCB events in March 2020, the Study includes a summary of the analysis and recommendations of the MWCB Task Force; an evaluation of the operation of the Pilot Rules during the March 2020 events; an evaluation of the design of the current MWCB system; and the Working Group's conclusions and recommendations.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">See</E>
                         Report of the Market-Wide Circuit Breaker (“MWCB”) Working Group Regarding the March 2020 MWCB Events, submitted March 31, 2021 (the “Study”), available at 
                        <E T="03">https://www.nyse.com/publicdocs/nyse/markets/nyse/Report_of_the_MarketWide_Circuit_Breaker_Working_Group.pdf.</E>
                    </P>
                </FTNT>
                <P>
                    In the Study, the Working Group concluded: (1) The MWCB mechanism set out in the Pilot Rules worked as intended during the March 2020 events; (2) the MWCB halts triggered in March 2020 appear to have had the intended effect of calming volatility in the market, without causing harm; (3) the design of the MWCB mechanism with respect to reference value (SPX), trigger levels (7%/13%/20%), and halt times (15 minutes) is appropriate; (4) the change implemented in Amendment 10 to the Plan to Address Extraordinary Market Volatility (the “Limit Up/Limit Down Plan” or “LULD Plan”) did not likely have any negative impact on MWCB functionality; and (5) no changes should be made to the mechanism to prevent the market from halting shortly after the opening of regular trading hours at 9:30 a.m. In light of the foregoing conclusions, the Working Group also made several recommendations, including that the Pilot Rules should be permanent without any changes.
                    <SU>14</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See id.</E>
                         at 46
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Proposal To Extend the Operation of the Pilot Rules Pending the Commission's Consideration of the New York Stock Exchange LLC's Filing To Make the Pilot Rules Permanent</HD>
                <P>
                    On July 16, 2021, an SRO member of the Working Group, the New York Stock Exchange (“NYSE”), proposed a rule change to make the Pilot Rules permanent, consistent with the Working Group's recommendations.
                    <SU>15</SU>
                    <FTREF/>
                     On August 27, 2021, the Commission extended its time to consider the proposed rule change to October 20, 2021.
                    <SU>16</SU>
                    <FTREF/>
                     The Exchange understands that upon approval of this proposal, the other national securities exchanges and FINRA, including the Exchange, will also submit substantively identical proposals to the Commission. The Exchange now proposes to extend the expiration date of its Pilot Rules to the end of business on March 18, 2022.
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 92428 (July 16, 2021), 86 FR 38776 (July 22, 2021) (SR-NYSE-2021-40).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 92785A (August 27, 2021), 86 FR 50202 (September 7, 2021) (SR-NYSE-2021-40).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2.  Statutory Basis </HD>
                <P>
                    The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
                    <SU>17</SU>
                    <FTREF/>
                     Specifically, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) 
                    <SU>18</SU>
                    <FTREF/>
                     requirements that the rules of an exchange be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest. Additionally, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) 
                    <SU>19</SU>
                    <FTREF/>
                     requirement that the rules of an exchange not be designed to permit unfair discrimination between customers, issuers, brokers, or dealers.
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         15 U.S.C. 78f(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         15 U.S.C. 78f(b)(5).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>
                    The MWCB mechanism under Rule 6.32.01 is an important, automatic mechanism that is invoked to promote stability and investor confidence during a period of significant stress when securities markets experience extreme broad-based declines. Extending the market-wide circuit breaker pilot for an additional five months would ensure the continued, uninterrupted operation of a consistent mechanism to halt trading across the U.S. markets while the Commission reviews the proposed rule change to make the Pilot Rules permanent.
                    <SU>20</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         
                        <E T="03">See supra</E>
                         notes 16 and 17.
                    </P>
                </FTNT>
                <P>The Exchange also believes that the proposed rule change promotes just and equitable principles of trade in that it promotes transparency and uniformity across markets concerning when and how to halt trading in all stocks as a result of extraordinary market volatility. Based on the foregoing, the Exchange believes the benefits to market participants from the MWCB under Rule 6.32.01 should continue on a pilot basis because the MWCB will promote fair and orderly markets and protect investors and the public interest.</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 because the proposal would ensure the continued, uninterrupted operation of a consistent mechanism to halt trading across the U.S. markets while the Commission reviews the proposed rule change to make the Pilot Rules permanent.</P>
                <P>Further, the Exchange understands that FINRA and other national securities exchanges will file proposals to extend their rules regarding the market-wide circuit breaker pilot. Thus, the proposed rule change will help to ensure consistency across market centers without implicating any competitive issues.</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>The Exchange neither solicited nor received comments on the proposed rule change.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    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 for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act 
                    <SU>21</SU>
                    <FTREF/>
                     and Rule 19b-4 (f)(6) 
                    <SU>22</SU>
                    <FTREF/>
                     thereunder.
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         17 CFR 240.19b-4 (f)(6). In addition, Rule 19b-4 (f)(6) requires a self-regulatory organization to give the Commission written notice of its intent to file the proposed rule change at least five business days prior to the date of filing of the proposed rule change, or such shorter time as designated by the Commission. The Exchange has satisfied this requirement.
                    </P>
                </FTNT>
                <P>
                    A proposed rule change filed under Rule 19b-4 (f)(6) 
                    <SU>23</SU>
                    <FTREF/>
                     normally does not become operative prior to 30 days after the date of the filing. However, pursuant to Rule 19b-4 (f)(6)(iii),
                    <SU>24</SU>
                    <FTREF/>
                     the 
                    <PRTPAGE P="58709"/>
                    Commission may designate a shorter time if such action is consistent with the protection of investors and the public interest. The Exchange asked that the Commission waive the 30 day operative delay so that the proposal may become operative immediately upon filing. Extending the Pilot Rules' effectiveness to the close of business on March 18, 2022 will extend the protections provided by the Pilot Rules, which would otherwise expire in less than 30 days. Waiver of the operative delay would therefore permit uninterrupted continuation of the MWCB pilot while the Commission reviews the NYSE's proposed rule change to make the Pilot Rules permanent. Therefore, the Commission hereby waives the 30-day operative delay and designates the proposed rule change as operative upon filing.
                    <SU>25</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         17 CFR 240.19b-4 (f)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         17 CFR 240.19b-4 (f)(6)(iii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>25</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. 
                        <E T="03">See</E>
                         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 under Section 19(b)(2)(B) 
                    <SU>26</SU>
                    <FTREF/>
                     of the Act to determine whether the proposed rule change should be approved or disapproved.
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         15 U.S.C. 78s(b)(2)(B).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">IV. Solicitation of Comments</HD>
                <P>Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:</P>
                <HD SOURCE="HD2">Electronic Comments</HD>
                <P>
                    • Use the Commission's internet comment form (
                    <E T="03">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-C2-2021-015 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-C2-2021-015. 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. All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-C2-2021-015 and should be submitted on or before November 12, 2021.
                </FP>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>27</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>27</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23023 Filed 10-21-21; 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. 34-93372; File No. SR-CBOE-2021-060]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Extend the Pilot Period Related to the Market-Wide Circuit Breaker in Rule 5.22</SUBJECT>
                <DATE>October 18, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on October 14, 2021, Cboe Exchange, Inc. (the “Exchange” or “Cboe Options”) filed with the Securities and Exchange Commission (the “Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the Exchange. The Exchange filed the proposal as a “non-controversial” proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act 
                    <SU>3</SU>
                    <FTREF/>
                     and Rule 19b-4(f)(6) thereunder.
                    <SU>4</SU>
                    <FTREF/>
                     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>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         15 U.S.C. 78s(b)(3)(A)(iii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         17 CFR 240.19b-4(f)(6).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>Cboe Exchange, Inc. (the “Exchange” or “Cboe Options”) proposes to extend the pilot period related to the market-wide circuit breaker in Rule 5.22. The text of the proposed rule change is provided in Exhibit 5.</P>
                <P>
                    The text of the proposed rule change is also available on the Exchange's website (
                    <E T="03">http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx</E>
                    ), at the Exchange's Office of the Secretary, and at the Commission's Public Reference Room.
                </P>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and the 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>The Exchange proposes to extend the pilot related to the market-wide circuit breaker in Rule 5.22 to the close of business on March 18, 2022.</P>
                <HD SOURCE="HD3">Background</HD>
                <P>
                    The Market-Wide Circuit Breaker (“MWCB”) rules, including the Exchange's Rule 5.22, provide an important, automatic mechanism that is invoked to promote stability and investor confidence during periods of significant stress when cash equities 
                    <PRTPAGE P="58710"/>
                    securities experience extreme market-wide declines. The MWCB rules are designed to slow the effects of extreme price declines through coordinated trading halts across both cash equity and equity options securities markets.
                </P>
                <P>
                    The cash equities rules governing MWCBs were first adopted in 1988 and, in 2012, all U.S. cash equity exchanges and FINRA amended their cash equities uniform rules on a pilot basis (the “Pilot Rules”, including Exchange Rule 5.22).
                    <SU>5</SU>
                    <FTREF/>
                     The Securities and Exchange Commission (the “Commission”) approved the Pilot Rules, the term of which was to coincide with the pilot period for the Plan to Address Extraordinary Market Volatility Pursuant to Rule 608 of Regulation NMS (the “LULD Plan”),
                    <SU>6</SU>
                    <FTREF/>
                     including any extensions to the pilot period for the LULD Plan. Though the LULD Plan was primarily designed for equity markets, the Exchange believed it would, indirectly, potentially impact the options markets as well. Thus, the Exchange has previously adopted and amended Rule 5.22 
                    <SU>7</SU>
                    <FTREF/>
                     (as well as other options pilot rules) to ensure the option markets were not harmed as a result of the Plan's implementation and implemented such rule on a pilot basis that has coincided with the pilot period for the Plan.
                    <SU>8</SU>
                    <FTREF/>
                     In April 2019, the Commission approved an amendment to the LULD Plan for it to operate on a permanent, rather than pilot, basis.
                    <SU>9</SU>
                    <FTREF/>
                     In light of the proposal to make the LULD Plan permanent, the Exchange amended Rule 5.22 to untie the pilot's effectiveness from that of the LULD Plan and to extend the pilot's effectiveness to the close of business on October 18, 2019.
                    <SU>10</SU>
                    <FTREF/>
                     The Exchange subsequently amended Rule 5.22 to extend the pilot to the close of business on October 18, 2020,
                    <SU>11</SU>
                    <FTREF/>
                     and later, on October 18, 2021.
                    <SU>12</SU>
                    <FTREF/>
                     The Exchange now proposes to amend Rule 5.22 to extend the pilot to the close of business on March 18, 2022. This filing does not propose any substantive or additional changes to Rule 5.22.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                          
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 67090 (May 31, 2012), 77 FR 33531 (June 6, 2012) (SR-BATS-2011-038; SR-BYX-2011-025; SR-BX-2011-068; SR-CBOE-2011-087; SR-C2-2011-024; SR-CHX-2011-30; SR-EDGA-2011-31; SR-EDGX-2011-30; SR-FINRA-2011-054; SR-ISE-2011-61; SR-NASDAQ-2011-131; SR-NSX-2011-11; SR-NYSE-2011-48; SRNYSEAmex-2011-73; SR-NYSEArca-2011-68; SR-Phlx-2011-129) (“Pilot Rules Approval Order”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                          
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 67091 (May 31, 2012), 77 FR 33498 (June 6, 2012). The LULD Plan provides a mechanism to address extraordinary market volatility in individual securities.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         In October 2019, the Exchange restructured its Rulebook and relocated previous Rule 6.3B, governing the MWCB mechanism, to current Rule 5.22. No substantive changes were made to the rule. 
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 87224 (October 4, 2019), 84 FR 54652 (October 10, 2019) (SR-CBOE-2019-081).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                          
                        <E T="03">See</E>
                         Securities Exchange Act Release Nos. 65438 (September 28, 2011), 76 FR 61447 (October 4, 2011) (SR-CBOE-2011-087) (amending Rule 5.22, prior Rule 6.3B, for determining when to halt trading in all stocks and stock options due to extraordinary market volatility); 68770 (January 30, 2013), 78 FR 8211 (February 5, 2013) (SR-CBOE-2013-011) (amending Rule 5.22, prior Rule 6.3B, to delay the operative date of the pilot to coincide with the initial date of operations of the Plan); and 85616 (April 11, 2019), 84 FR 16093 (April 17, 2019) (SR-CBOE-2019-020) (proposal to extend the pilot for certain options pilots, including Rule 5.22, prior Rule 6.3B).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                          
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 85623 (April 11, 2019), 84 FR 16086 (April 17, 2019) (Order Approving Amendment No. 18).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                          
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 85616 (April 11, 2019), 84 FR 16093 (April 17, 2019) (SR-CBOE-2019-020) (proposal to extend the pilot for certain options pilots, including Rule 5.22, prior Rule 6.3B).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                          
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 87341 (October 18, 2019), 84 FR 57081 (October 24, 2019) (SR-CBOE-2020-100).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                          
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 90165 (October 13, 2020), 85 FR 66391 (October 19, 2020) (SR-CBOE-2020-098).
                    </P>
                </FTNT>
                <P>As stated above, because all U.S. equity exchanges and FINRA adopted uniform Pilot Rules relating to market-wide circuit breakers in 2012, the Exchange, too, adopted a MWCB mechanism on a pilot basis pursuant to Rule 5.22. Pursuant to Rule 5.22, a market-wide trading halt will be triggered if the S&amp;P 500 Index declines in price by specified percentages from the prior day's closing price of that index. Currently, the triggers are set at three circuit breaker thresholds: 7% (Level 1), 13% (Level 2), and 20% (Level 3). A market decline that triggers a Level 1 or Level 2 halt after 9:30 a.m. ET and before 3:25 p.m. ET would halt market-wide trading for 15 minutes, while a similar market decline at or after 3:25 p.m. ET would not halt market-wide trading. A market decline that triggers a Level 3 halt, at any time during the trading day, would halt market-wide trading for the remainder of the trading day.</P>
                <HD SOURCE="HD3">The MWCB Task Force and the March 2020 MWCB Events</HD>
                <P>In late 2019, Commission staff requested the formation of a MWCB Task Force (“Task Force”) to evaluate the operation and design of the MWCB mechanism. The Task Force included representatives from the SROs, the Commission, CME, the Commodity Futures Trading Commission (“CFTC”), and the securities industry and conducted several organizational meetings in December 2019 and January 2020. In Spring 2020, the MWCB mechanism proved itself to be an effective tool for protecting markets through turbulent times. In March 2020, at the outset of the worldwide COVID-19 pandemic, U.S. equities markets experienced four MWCB Level 1 halts, on March 9, 12, 16, and 18, 2020. In each instance, the markets halted as intended upon a 7% drop in the S&amp;P 500 Index, and resumed as intended 15 minutes later.</P>
                <P>
                    In response to these events, in the Spring and Summer of 2020, the Task Force held ten meetings that were attended by Commission staff, with the goal of performing an expedited review of the March 2020 halts and identifying any areas where the MWCB mechanism had not worked properly. Given the risk of unintended consequences, the Task Force did not recommend changes that were not rooted in a noted deficiency. The Task Force recommended creating a process for a backup reference price in the event that SPX were to become unavailable, and enhancing functional MWCB testing. The Task Force also asked CME to consider modifying its rules to enter into a limit-down state in the futures pre-market after a 7% decline instead of 5%. CME made the requested change, which became effective on October 12, 2020.
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                          
                        <E T="03">See https://www.cmegroup.com/content/dam/cmegroup/market-regulation/rulefilings/2020/9/20-392_1.pdf;</E>
                          
                        <E T="03">https://www.cmegroup.com/content/dam/cmegroup/marketregulation/rule-filings/2020/9/20-392_2.pdf.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD3">The MWCB Working Group's Study</HD>
                <P>
                    On September 17, 2020, the Director of the Commission's Division of Trading and Markets asked the SROs to conduct a more complete study of the design and operation of the Pilot Rules and the LULD Plan during the period of volatility in the Spring of 2020. In response to the request, the SROs created a MWCB “Working Group” composed of SRO representatives and industry advisers that included members of the advisory committees to both the LULD Plan and the NMS Plans governing the collection, consolidation, and dissemination of last-sale transaction reports and quotations in NMS Stocks. The Working Group met regularly from September 2020 through March 2021 to consider the Commission's request, review data, and compile its study. The Working Group's efforts in this respect incorporated and built on the work of an MWCB Task Force. The Working Group submitted its study to the Commission on March 31, 2021 (the “Study”).
                    <SU>14</SU>
                    <FTREF/>
                     In addition to a 
                    <PRTPAGE P="58711"/>
                    timeline of the MWCB events in March 2020, the Study includes a summary of the analysis and recommendations of the MWCB Task Force; an evaluation of the operation of the Pilot Rules during the March 2020 events; an evaluation of the design of the current MWCB system; and the Working Group's conclusions and recommendations.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                          
                        <E T="03">See</E>
                         Report of the Market-Wide Circuit Breaker (“MWCB”) Working Group Regarding the March 2020 MWCB Events, submitted March 31, 2021 (the 
                        <PRTPAGE/>
                        “Study”), available at 
                        <E T="03">https://www.nyse.com/publicdocs/nyse/markets/nyse/Report_of_the_MarketWide_Circuit_Breaker_Working_Group.pdf.</E>
                    </P>
                </FTNT>
                <P>
                    In the Study, the Working Group concluded: (1) The MWCB mechanism set out in the Pilot Rules worked as intended during the March 2020 events; (2) the MWCB halts triggered in March 2020 appear to have had the intended effect of calming volatility in the market, without causing harm; (3) the design of the MWCB mechanism with respect to reference value (SPX), trigger levels (7%/13%/20%), and halt times (15 minutes) is appropriate; (4) the change implemented in Amendment 10 to the Plan to Address Extraordinary Market Volatility (the “Limit Up/Limit Down Plan” or “LULD Plan”) did not likely have any negative impact on MWCB functionality; and (5) no changes should be made to the mechanism to prevent the market from halting shortly after the opening of regular trading hours at 9:30 a.m. In light of the foregoing conclusions, the Working Group also made several recommendations, including that the Pilot Rules should be permanent without any changes.
                    <SU>15</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                          
                        <E T="03">See id.</E>
                         at 46
                    </P>
                </FTNT>
                <P>Proposal To Extend the Operation of the Pilot Rules Pending the Commission's Consideration of the New York Stock Exchange LLC's Filing To Make the Pilot Rules Permanent</P>
                <P>
                    On July 16, 2021, an SRO member of the Working Group, the New York Stock Exchange (“NYSE”), proposed a rule change to make the Pilot Rules permanent, consistent with the Working Group's recommendations.
                    <SU>16</SU>
                    <FTREF/>
                     On August 27, 2021, the Commission extended its time to consider the proposed rule change to October 20, 2021.
                    <SU>17</SU>
                    <FTREF/>
                     The Exchange understands that upon approval of this proposal, the other national securities exchanges and FINRA, including the Exchange, will also submit substantively identical proposals to the Commission. The Exchange now proposes to extend the expiration date of the Pilot Rules to the end of business on March 18, 2022.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                          
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 92428 (July 16, 2021), 86 FR 38776 (July 22, 2021) (SR-NYSE-2021-40).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                          
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 92785A (August 27, 2021), 86 FR 50202 (September 7, 2021) (SR-NYSE-2021-40).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2.  Statutory Basis </HD>
                <P>
                    The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
                    <SU>18</SU>
                    <FTREF/>
                     Specifically, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) 
                    <SU>19</SU>
                    <FTREF/>
                     requirements that the rules of an exchange be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest. Additionally, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) 
                    <SU>20</SU>
                    <FTREF/>
                     requirement that the rules of an exchange not be designed to permit unfair discrimination between customers, issuers, brokers, or dealers.
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         15 U.S.C. 78f(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         15 U.S.C. 78f(b)(5).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                          
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>
                    The MWCB mechanism under Rule 5.22 is an important, automatic mechanism that is invoked to promote stability and investor confidence during a period of significant stress when securities markets experience extreme broad-based declines. Extending the market-wide circuit breaker pilot for an additional five months would ensure the continued, uninterrupted operation of a consistent mechanism to halt trading across the U.S. markets while the Commission reviews the proposed rule change to make the Pilot Rules permanent.
                    <SU>21</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                          
                        <E T="03">See supra</E>
                         notes 16 and 17.
                    </P>
                </FTNT>
                <P>The Exchange also believes that the proposed rule change promotes just and equitable principles of trade in that it promotes transparency and uniformity across markets concerning when and how to halt trading in all stocks as a result of extraordinary market volatility. Based on the foregoing, the Exchange believes the benefits to market participants from the MWCB under Rule 5.22 should continue on a pilot basis because the MWCB will promote fair and orderly markets and protect investors and the public interest.</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 because the proposal would ensure the continued, uninterrupted operation of a consistent mechanism to halt trading across the U.S. markets while the Commission reviews the proposed rule change to make the Pilot Rules permanent.</P>
                <P>Further, the Exchange understands that FINRA and other national securities exchanges will file proposals to extend their rules regarding the market-wide circuit breaker pilot. Thus, the proposed rule change will help to ensure consistency across market centers without implicating any competitive issues.</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>The Exchange neither solicited nor received comments on the proposed rule change.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    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 for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act 
                    <SU>22</SU>
                    <FTREF/>
                     and Rule 19b-4 (f)(6) 
                    <SU>23</SU>
                    <FTREF/>
                     thereunder.
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         17 CFR 240.19b-4 (f)(6). In addition, Rule 19b-4 (f)(6) requires a self-regulatory organization to give the Commission written notice of its intent to file the proposed rule change at least five business days prior to the date of filing of the proposed rule change, or such shorter time as designated by the Commission. The Exchange has satisfied this requirement.
                    </P>
                </FTNT>
                <P>
                    A proposed rule change filed under Rule 19b-4 (f)(6) 
                    <SU>24</SU>
                    <FTREF/>
                     normally does not become operative prior to 30 days after the date of the filing. However, pursuant to Rule 19b-4 (f)(6)(iii),
                    <SU>25</SU>
                    <FTREF/>
                     the Commission may designate a shorter time if such action is consistent with the protection of investors and the public interest. The Exchange asked that the Commission waive the 30 day operative delay so that the proposal may become operative immediately upon filing. Extending the Pilot Rules' effectiveness 
                    <PRTPAGE P="58712"/>
                    to the close of business on March 18, 2022 will extend the protections provided by the Pilot Rules, which would otherwise expire in less than 30 days. Waiver of the operative delay would therefore permit uninterrupted continuation of the MWCB pilot while the Commission reviews the NYSE's proposed rule change to make the Pilot Rules permanent. Therefore, the Commission hereby waives the 30-day operative delay and designates the proposed rule change as operative upon filing.
                    <SU>26</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         17 CFR 240.19b-4 (f)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         17 CFR 240.19b-4(f)(6)(iii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>26</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. 
                        <E T="03">See</E>
                         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 under Section 19(b)(2)(B) 
                    <SU>27</SU>
                    <FTREF/>
                     of the Act to determine whether the proposed rule change should be approved or disapproved.
                </P>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         15 U.S.C. 78s(b)(2)(B).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">IV. Solicitation of Comments</HD>
                <P>Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:</P>
                <HD SOURCE="HD2">Electronic Comments</HD>
                <P>
                    • Use the Commission's internet comment form (
                    <E T="03">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-CBOE-2021-060 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-CBOE-2021-060. 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. All comments received will be posted without change; the Commission does not edit personal identifying information from submissions.
                </FP>
                <P>You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-CBOE-2021-060 and should be submitted on or before November 12, 2021.</P>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>28</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>28</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23022 Filed 10-21-21; 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. 34-93380; File No. 265-33]</DEPDOC>
                <SUBJECT>Asset Management Advisory Committee</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Securities and Exchange Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        Notice is being provided that the Securities and Exchange Commission Asset Management Advisory Committee (“AMAC”) will hold a public meeting on October 28, 2021, by remote means. The meeting will begin at 10:00 a.m. (ET) and will be open to the public via webcast on the Commission's website at 
                        <E T="03">www.sec.gov.</E>
                         Persons needing special accommodations to take part because of a disability should notify the contact person listed below. The public is invited to submit written statements to the Committee. The meeting will include a discussion of matters in the asset management industry relating to the Evolution of Advice and the Small Advisers and Small Funds Subcommittees, including panel discussions and potential recommendations.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The public meeting will be held on October 28, 2021. Written statements should be received on or before October 25, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The meeting will be held by remote means and webcast on 
                        <E T="03">www.sec.gov.</E>
                         Written statements may be submitted by any of the following methods. To help us process and review your statement more efficiently, please use only one method. At this time, electronic statements are preferred.
                    </P>
                </ADD>
                <HD SOURCE="HD2">Electronic Statements</HD>
                <P>
                    • Use the Commission's internet submission form (
                    <E T="03">http://www.sec.gov/rules/other.shtml</E>
                    ); or
                </P>
                <P>
                    • Send an email message to 
                    <E T="03">rule-comments@sec.gov.</E>
                     Please include File Number 265-33 on the subject line; or
                </P>
                <HD SOURCE="HD2">Paper Statements</HD>
                <P>• Send paper statements to Vanessa Countryman, Federal Advisory Committee Management Officer, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.</P>
                <FP>
                    All submissions should refer to File No. 265-33. This file number should be included on the subject line if email is used. The Commission will post all statements on the Commission's website at (
                    <E T="03">http://www.sec.gov/comments/265-33/265-33.htm</E>
                    ).
                </FP>
                <P>Statements also will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Room 1580, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Operating conditions may limit access to the Commission's public reference room.</P>
                <P>All statements received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from submissions. You should submit only information that you wish to make available publicly.</P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Christian Broadbent, Senior Special Counsel, Neil Lombardo, Senior Special Counsel, or Jay Williamson, Branch Chief, at (202) 551-6720, Division of Investment Management, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-3628.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    In accordance with Section 10(a) of the Federal Advisory Committee Act, 5 U.S.C.-App. 1, and the regulations thereunder, Sarah ten Siethoff, 
                    <PRTPAGE P="58713"/>
                    Designated Federal Officer of the Committee, has ordered publication of this notice.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Due to scheduling challenges, earlier advance publication was not possible.
                    </P>
                </FTNT>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>Vanessa A. Countryman,</NAME>
                    <TITLE>Committee Management Officer. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23072 Filed 10-21-21; 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. 34-93376; File No. SR-LTSE-2021-06]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Long-Term Stock Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Extend the Date of the Pilot Related to the Market-Wide Circuit Breaker in Rule 11.280</SUBJECT>
                <DATE>October 18, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on October 15, 2021, Long-Term Stock Exchange, Inc. (“LTSE” or the “Exchange”) filed with the Securities and Exchange Commission (the “Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the self-regulatory organization. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         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>LTSE proposes a rule change to extend the pilot related to the market-wide circuit breaker in Rule 11.280.</P>
                <P>
                    The text of the proposed rule change is available at the Exchange's website at 
                    <E T="03">https://longtermstockexchange.com/,</E>
                     at the principal office of the Exchange, and at the Commission's Public Reference Room.
                </P>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement on the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <P>In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The self-regulatory organization 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>The Exchange proposes to extend the pilot related to the market-wide circuit breaker in Rule 11.280 to the close of business on March 18, 2022.</P>
                <HD SOURCE="HD3">Background</HD>
                <P>The Market-Wide Circuit Breaker (“MWCB”) rules, including the Exchange's Rule 11.280, provide an important, automatic mechanism that is invoked to promote stability and investor confidence during periods of significant stress when cash equities securities experience extreme market-wide declines. The MWCB rules are designed to slow the effects of extreme price declines through coordinated trading halts across both cash equity and equity options securities markets.</P>
                <P>
                    The cash equities rules governing MWCBs were first adopted in 1988 and, in 2012, all U.S. cash equity exchanges and FINRA amended their cash equities uniform rules on a pilot basis (the “Pilot Rules”).
                    <SU>3</SU>
                    <FTREF/>
                     The Pilot Rules currently provide for trading halts in all cash equity securities during a severe market decline as measured by a single-day decline in the S&amp;P 500 Index (“SPX”).
                    <SU>4</SU>
                    <FTREF/>
                     Under the Pilot Rules, a market-wide trading halt will be triggered if SPX declines in price by specified percentages from the prior day's closing price of that index. The triggers are set at three circuit breaker thresholds: 7% (Level 1), 13% (Level 2), and 20% (Level 3). A market decline that triggers a Level 1 or Level 2 halt after 9:30 a.m. and before 3:25 p.m. would halt market-wide trading for 15 minutes, while a similar market decline at or after 3:25 p.m. would not halt market-wide trading. (Level 1 and Level 2 halts may occur only once a day.) A market decline that triggers a Level 3 halt at any time during the trading day would halt market-wide trading for the remainder of the trading day.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 67090 (May 31, 2012), 77 FR 33531 (June 6, 2012) (SR-BATS-2011-038; SR-BYX-2011-025; SR-BX-2011-068; SR-CBOE-2011-087; SR-C2-2011-024; SR-CHX-2011-30; SR-EDGA-2011-31; SR-EDGX-2011-30; SR-FINRA-2011-054; SR-ISE-2011-61; SR-NASDAQ-2011-131; SR-NSX-2011-11; SR-NYSE-2011-48; SR-NYSEAmex-2011-73; SR-NYSEArca-2011-68; SR-Phlx-2011-129) (“Pilot Rules Approval Order”). LTSE adopted Pilot Rules as part of its approval as a national securities exchange. 
                        <E T="03">See generally</E>
                         [cite to Form 1 approval][sic].
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         The rules of the equity options exchanges similarly provide for a halt in trading if the cash equity exchanges invoke a MWCB Halt. 
                        <E T="03">See, e.g.,</E>
                         NYSE Arca Rule 6.65-O(d)(4).
                    </P>
                </FTNT>
                <P>
                    The Commission approved the Pilot Rules, the term of which was to coincide with the pilot period for the Plan to Address Extraordinary Market Volatility Pursuant to Rule 608 of Regulation NMS (the “LULD Plan”),
                    <SU>5</SU>
                    <FTREF/>
                     including any extensions to the pilot period for the LULD Plan.
                    <SU>6</SU>
                    <FTREF/>
                     In April 2019, the Commission approved an amendment to the LULD Plan for it to operate on a permanent, rather than pilot, basis.
                    <SU>7</SU>
                    <FTREF/>
                     In conjunction with the proposal to make the LULD Plan permanent, the Exchange amended Rule 11.280 to untie the Pilot Rules' effectiveness from that of the LULD Plan and to extend the Pilot Rules' effectiveness to the close of business on October 18, 2020.
                    <SU>8</SU>
                    <FTREF/>
                     The Exchange subsequently amended Rule 11.280, to extend the Pilot Rules' effectiveness for an additional year to the close of business on October 18, 2021.
                    <SU>9</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 67091 (May 31, 2012), 77 FR 33498 (June 6, 2012). The LULD Plan provides a mechanism to address extraordinary market volatility in individual securities.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See e.g.</E>
                         Securities Exchange Act Release Nos. 67090 (May 31, 2012), 77 FR 33531 (June 6, 2012) (SR-NYSE-2011-48) (Approval Order); and 68784 (January 31, 2013), 78 FR 8662 (February 6, 2013) (SR-NYSE-2013-10).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 85623 (April 11, 2019), 84 FR 16086 (April 17, 2019).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See https://www.sec.gov/rules/sro/ltse/2019/34-87357.pdf.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         See Securities Exchange Act Release No. 90125 (October 8, 2020), 85 FR 65114 (October 14, 2020) (SR-LTSE-2020-18).
                    </P>
                </FTNT>
                <P>The Exchange now proposes to amend Rule 11.280 to extend the pilot to the close of business on March 18, 2022. This filing does not propose any substantive or additional changes to Rule 11.280.</P>
                <HD SOURCE="HD3">The MWCB Task Force and the March 2020 MWCB Events</HD>
                <P>In late 2019, Commission staff requested the formation of a MWCB Task Force (“Task Force”) to evaluate the operation and design of the MWCB mechanism. The Task Force included representatives from the SROs, the Commission, CME, the Commodity Futures Trading Commission (“CFTC”), and the securities industry and conducted several organizational meetings in December 2019 and January 2020.</P>
                <P>
                    In Spring 2020, the MWCB mechanism proved itself to be an effective tool for protecting markets through turbulent times. In March 2020, at the outset of the worldwide COVID-
                    <PRTPAGE P="58714"/>
                    19 pandemic, U.S. equities markets experienced four MWCB Level 1 halts, on March 9, 12, 16, and 18, 2020. In each instance, the markets halted as intended upon a 7% drop in the S&amp;P 500 Index, and resumed as intended 15 minutes later.
                </P>
                <P>
                    In response to these events, in the Spring and Summer of 2020, the Task Force held ten meetings that were attended by Commission staff, with the goal of performing an expedited review of the March 2020 halts and identifying any areas where the MWCB mechanism had not worked properly. Given the risk of unintended consequences, the Task Force did not recommend changes that were not rooted in a noted deficiency. The Task Force recommended creating a process for a backup reference price in the event that SPX were to become unavailable, and enhancing functional MWCB testing. The Task Force also asked CME to consider modifying its rules to enter into a limit-down state in the futures pre-market after a 7% decline instead of 5%. CME made the requested change, which became effective on October 12, 2020.
                    <SU>10</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See https://www.cmegroup.com/content/dam/cmegroup/market-regulation/rule-filings/2020/9/20-392_1.pdf; https://www.cmegroup.com/content/dam/cmegroup/market-regulation/rule-filings/2020/9/20-392_2.pdf.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD3">The MWCB Working Group's Study</HD>
                <P>On September 17, 2020, the Director of the Commission's Division of Trading and Markets asked the SROs to conduct a more complete study of the design and operation of the Pilot Rules and the LULD Plan during the period of volatility in the Spring of 2020.</P>
                <P>In response to the request, the SROs created a MWCB “Working Group” composed of SRO representatives and industry advisers that included members of the advisory committees to both the LULD Plan and the NMS Plans governing the collection, consolidation, and dissemination of last-sale transaction reports and quotations in NMS Stocks. The Working Group met regularly from September 2020 through March 2021 to consider the Commission's request, review data, and compile its study. The Working Group's efforts in this respect incorporated and built on the work of an MWCB Task Force.</P>
                <P>
                    The Working Group submitted its study to the Commission on March 31, 2021 (the “Study”).
                    <SU>11</SU>
                    <FTREF/>
                     In addition to a timeline of the MWCB events in March 2020, the Study includes a summary of the analysis and recommendations of the MWCB Task Force; an evaluation of the operation of the Pilot Rules during the March 2020 events; an evaluation of the design of the current MWCB system; and the Working Group's conclusions and recommendations.
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See Report of the Market-Wide Circuit Breaker (“MWCB”) Working Group Regarding the March 2020 MWCB Events,</E>
                         submitted March 31, 2021 (the “Study”), available at 
                        <E T="03">https://www.nyse.com/publicdocs/nyse/markets/nyse/Report_of_the_Market-Wide_Circuit_Breaker_Working_Group.pdf.</E>
                    </P>
                </FTNT>
                <P>In the Study, the Working Group concluded: (1) The MWCB mechanism set out in the Pilot Rules worked as intended during the March 2020 events; (2) the MWCB halts triggered in March 2020 appear to have had the intended effect of calming volatility in the market, without causing harm; (3) the design of the MWCB mechanism with respect to reference value (SPX), trigger levels (7%/13%/20%), and halt times (15 minutes) is appropriate; (4) the change implemented in Amendment 10 to the Plan to Address Extraordinary Market Volatility (the “Limit Up/Limit Down Plan” or “LULD Plan”) did not likely have any negative impact on MWCB functionality; and (5) no changes should be made to the mechanism to prevent the market from halting shortly after the opening of regular trading hours at 9:30 a.m.</P>
                <P>
                    In light of the foregoing conclusions, the Working Group also made several recommendations, including that the Pilot Rules should be permanent without any changes.
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See id.</E>
                         at 46.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Proposal To Extend the Operation of the Pilot Rules Pending the Commission's Consideration of the Exchange's Filing To Make the Pilot Rules Permanent</HD>
                <P>
                    On July 16, 2021, the NYSE proposed a rule change to make the Pilot Rules permanent, consistent with the Working Group's recommendations.
                    <SU>13</SU>
                    <FTREF/>
                     On August 27, 2021, the Commission extended its time to consider the proposed rule change to October 20, 2021.
                    <SU>14</SU>
                    <FTREF/>
                     The Exchange now proposes to extend the expiration date of the Pilot Rules to the close of business on March 18, 2022.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 92428 (July 16, 2021), 86 FR 38776 (July 22, 2021) (SR-NYSE-2021-40).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 92785A (August 27, 2021), 86 FR 50202 (September 7, 2021) (SR-NYSE-2021-40).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">b. Statutory Basis</HD>
                <P>
                    The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
                    <SU>15</SU>
                    <FTREF/>
                     in general, and furthers the objectives of Section 6(b)(5) of the Act,
                    <SU>16</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. The market-wide circuit breaker mechanism under Rule 11.280 is an important, automatic mechanism that is invoked to promote stability and investor confidence during a period of significant stress when securities markets experience extreme broad-based declines. Extending the market-wide circuit breaker pilot for an additional five months would ensure the continued, uninterrupted operation of a consistent mechanism to halt trading across the U.S. markets while the Commission reviews the Exchange's[sic] proposed rule change to make the Pilot Rules permanent.
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         15 U.S.C. 78f(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         15 U.S.C. 78f(b)(5).
                    </P>
                </FTNT>
                <P>The Exchange also believes that the proposed rule change promotes just and equitable principles of trade in that it promotes transparency and uniformity across markets concerning when and how to halt trading in all stocks as a result of extraordinary market volatility. Based on the foregoing, the Exchange believes the benefits to market participants from Pilot Rules should continue on a pilot basis because they will promote fair and orderly markets and protect investors and the public interest.</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 because the proposal would ensure the continued, uninterrupted operation of a consistent mechanism to halt trading across the U.S. markets while the Commission reviews the Exchange's[sic] proposed rule change to make the Pilot Rules permanent.</P>
                <P>Further, the Exchange understands that FINRA and other national securities exchanges have filed or will file proposals to extend their rules regarding the market-wide circuit breaker pilot. Thus, the proposed rule change will help to ensure consistency across market centers without implicating any competitive issues.</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.
                    <PRTPAGE P="58715"/>
                </P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act 
                    <SU>17</SU>
                    <FTREF/>
                     and Rule 19b-4(f)(6) thereunder.
                    <SU>18</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 for 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 
                    <SU>19</SU>
                    <FTREF/>
                     and Rule 19b-4(f)(6)(iii) thereunder.
                    <SU>20</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         15 U.S.C. 78s(b)(3)(A)(iii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         17 CFR 240.19b-4(f)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6) requires a self-regulatory organization to give the Commission written notice of its intent to file the proposed rule change at least five business days prior to the date of filing of the proposed rule change, or such shorter time as designated by the Commission. The Commission has waived this requirement.
                    </P>
                </FTNT>
                <P>
                    A proposed rule change filed under Rule 19b-4(f)(6) 
                    <SU>21</SU>
                    <FTREF/>
                     normally does not become operative prior to 30 days after the date of the filing. However, pursuant to Rule 19b-4(f)(6)(iii),
                    <SU>22</SU>
                    <FTREF/>
                     the Commission may designate a shorter time if such action is consistent with the protection of investors and the public interest. The Exchange asked that the Commission waive the 30 day operative delay so that the proposal may become operative immediately upon filing. Extending the Pilot Rules' effectiveness to the close of business on March 18, 2022 will extend the protections provided by the Pilot Rules, which would otherwise expire in less than 30 days. Waiver of the operative delay would therefore permit uninterrupted continuation of the MWCB pilot while the Commission reviews the NYSE's proposed rule change to make the Pilot Rules permanent. Therefore, the Commission hereby waives the 30-day operative delay and designates the proposed rule change as operative upon filing.
                    <SU>23</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         17 CFR 240.19b-4(f)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         17 CFR 240.19b-4(f)(6)(iii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</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. 
                        <E T="03">See</E>
                         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 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-LTSE-2021-06 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-LTSE-2021-06. 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 LTSE and on its internet website at 
                    <E T="03">https://longtermstockexchange.com/.</E>
                </FP>
                <P>All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-LTSE-2021-06 and should be submitted on or before November 12, 2021.</P>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>24</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>24</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23024 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">SOCIAL SECURITY ADMINISTRATION</AGENCY>
                <DEPDOC>[Docket No. SSA-2021-0033]</DEPDOC>
                <SUBJECT>Cost-of-Living Increase and Other Determinations for 2022</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Social Security Administration.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Under title II of the Social Security Act (Act), there will be a 5.9 percent cost-of-living increase in Social Security benefits effective December 2021. In addition, the national average wage index for 2020 is $55,628.60. The cost-of-living increase and national average wage index affect other program parameters as described below.</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Kathleen K. Sutton, Office of the Chief Actuary, Social Security Administration, 6401 Security Boulevard, Baltimore, MD 21235, (410) 965-3000. Information relating to this announcement is available on our internet site at 
                        <E T="03">www.socialsecurity.gov/oact/cola/index.html.</E>
                         For information on eligibility or claiming benefits, call 1-800-772-1213 (TTY 1-800-325-0778), or visit our internet site at 
                        <E T="03">www.socialsecurity.gov</E>
                         online.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Because of the 5.9 percent cost-of-living increase, the following items will increase for 2022;</P>
                <P>(1) The maximum Federal Supplemental Security Income (SSI) monthly payment amounts for 2022 under title XVI of the Act will be $841 for an eligible individual, $1,261 for an eligible individual with an eligible spouse, and $421 for an essential person;</P>
                <P>(2) The special benefit amount under title VIII of the Act for certain World War II veterans will be $630.75 for 2022;</P>
                <P>(3) The student earned income exclusion under title XVI of the Act will be $2,040 per month in 2022, but not more than $8,230 for all of 2022;</P>
                <P>
                    (4) The dollar fee limit for services performed as a representative payee will be $48 per month ($89 per month in the 
                    <PRTPAGE P="58716"/>
                    case of a beneficiary who is disabled and has an alcoholism or drug addiction condition that leaves him or her incapable of managing benefits) in 2022; and
                </P>
                <P>(5) The dollar limit on the administrative-cost fee assessment charged to an appointed representative such as an attorney, agent, or other person who represents claimants will be $104 beginning in December 2021.</P>
                <P>The national average wage index for 2020 is $55,628.60. This index affects the following amounts:</P>
                <P>(1) The Old-Age, Survivors, and Disability Insurance (OASDI) contribution and benefit base will be $147,000 for remuneration paid in 2022 and self-employment income earned in taxable years beginning in 2022;</P>
                <P>
                    (2) The monthly exempt amounts under the OASDI retirement earnings test for taxable years ending in calendar year 2022 will be $1,630 for beneficiaries who will attain their Normal Retirement Age (NRA) (defined in the 
                    <E T="03">Retirement Earnings Test Exempt Amounts</E>
                     section below) after 2022 and $4,330 for those who attain NRA in 2022;
                </P>
                <P>(3) The dollar amounts (bend points) used in the primary insurance amount (PIA) formula for workers who become eligible for benefits, or who die before becoming eligible, in 2022 will be $1,024 and $6,172;</P>
                <P>(4) The bend points used in the formula for computing maximum family benefits for workers who become eligible for retirement benefits, or who die before becoming eligible, in 2022 will be $1,308, $1,889, and $2,463;</P>
                <P>(5) The taxable earnings a person must have to be credited with a quarter of coverage in 2022 will be $1,510;</P>
                <P>(6) The “old-law” contribution and benefit base under title II of the Act will be $109,200 for 2022;</P>
                <P>(7) The monthly amount deemed to constitute substantial gainful activity (SGA) for statutorily blind persons in 2022 will be $2,260. The corresponding amount for non-blind disabled persons will be $1,350;</P>
                <P>(8) The earnings threshold establishing a month as a part of a trial work period will be $970 for 2022; and</P>
                <P>(9) Coverage thresholds for 2022 will be $2,400 for domestic workers and $2,000 for election officials and election workers.</P>
                <P>According to section 215(i)(2)(D) of the Act, we must publish the benefit increase percentage and the revised table of “special minimum” benefits within 45 days after the close of the third calendar quarter of 2021. We must also publish the following by November 1: The national average wage index for 2020 (215(a)(1)(D)), the OASDI fund ratio for 2021 (section 215(i)(2)(C)(ii)), the OASDI contribution and benefit base for 2022 (section 230(a)), the earnings required to be credited with a quarter of coverage in 2022 (section 213(d)(2)), the monthly exempt amounts under the Social Security retirement earnings test for 2022 (section 203(f)(8)(A)), the formula for computing a PIA for workers who first become eligible for benefits or die in 2022 (section 215(a)(1)(D)), and the formula for computing the maximum benefits payable to the family of a worker who first becomes eligible for old-age benefits or dies in 2022 (section 203(a)(2)(C)).</P>
                <HD SOURCE="HD1">Cost-of-Living Increases</HD>
                <HD SOURCE="HD2">General</HD>
                <P>The cost-of-living increase is 5.9 percent for monthly benefits under title II and for monthly payments under title XVI of the Act. Under title II, OASDI monthly benefits will increase by 5.9 percent for individuals eligible for December 2021 benefits, payable in January 2022 and thereafter. We base this increase on the authority contained in section 215(i) of the Act.</P>
                <P>Pursuant to section 1617 of the Act, Federal SSI benefit rates will also increase by 5.9 percent effective for payments made for January 2022 but paid on December 30, 2021.</P>
                <HD SOURCE="HD2">Computation</HD>
                <P>Computation of the cost-of-living increase is based on an increase in a Consumer Price Index produced by the Bureau of Labor Statistics. At the time the Act was amended to provide automatic cost-of-living increases starting in 1975, only one Consumer Price Index existed, namely the Consumer Price Index for Urban Wage Earners and Clerical Workers. Although the Bureau of Labor Statistics has since developed other consumer price indices, we follow precedent by continuing to use the Consumer Price Index for Urban Wage Earners and Clerical Workers. We refer to this index in the following paragraphs as the CPI.</P>
                <P>Section 215(i)(1)(B) of the Act defines a “computation quarter” to be a third calendar quarter in which the average CPI exceeded the average CPI in the previous computation quarter. The last cost-of-living increase, effective for those eligible to receive title II benefits for December 2020, was based on the CPI increase from the third quarter of 2019 to the third quarter of 2020. Therefore, the last computation quarter is the third quarter of 2020. The law states that a cost-of-living increase for benefits is determined based on the percentage increase, if any, in the CPI from the last computation quarter to the third quarter of the current year. Therefore, we compute the increase in the CPI from the third quarter of 2020 to the third quarter of 2021.</P>
                <P>Section 215(i)(1) of the Act states that the CPI for a cost-of-living computation quarter is the arithmetic mean of this index for the 3 months in that quarter. In accordance with 20 CFR 404.275, we round the arithmetic mean, if necessary, to the nearest 0.001. The CPI for each month in the quarter ending September 30, 2020, the last computation quarter, is: For July 2020, 252.636; for August 2020, 253.597; and for September 2020, 254.004. The arithmetic mean for the calendar quarter ending September 30, 2020 is 253.412. The CPI for each month in the quarter ending September 30, 2021, is: For July 2021, 267.789; for August 2021, 268.387; and for September 2021, 269.086. The arithmetic mean for the calendar quarter ending September 30, 2021 is 268.421. The CPI for the calendar quarter ending September 30, 2021, exceeds that for the calendar quarter ending September 30, 2020, by 5.9 percent (rounded to the nearest 0.1). Therefore, beginning December 2021 a cost-of-living benefit increase of 5.9 percent is effective for benefits under title II of the Act.</P>
                <P>Section 215(i) also specifies that a benefit increase under title II, effective for December of any year, will be limited to the increase in the national average wage index for the prior year if the OASDI fund ratio for that year is below 20.0 percent. The OASDI fund ratio for a year is the ratio of the combined assets of the OASDI Trust Funds at the beginning of that year to the combined expenditures of these funds during that year. For 2021, the OASDI fund ratio is assets of $2,908,286 million divided by estimated expenditures of $1,146,226 million, or 253.7 percent. Because the 253.7 percent OASDI fund ratio exceeds 20.0 percent, the benefit increase for December 2021 is not limited to the increase in the national average wage index.</P>
                <HD SOURCE="HD1">Program Amounts That Change Based on the Cost-of-Living Increase</HD>
                <P>
                    The following program amounts change based on the cost-of-living increase: (1) Title II benefits; (2) title XVI payments; (3) title VIII benefits; (4) the student earned income exclusion; (5) the fee for services performed by a representative payee; and (6) the appointed representative fee assessment.
                    <PRTPAGE P="58717"/>
                </P>
                <HD SOURCE="HD2">Title II Benefit Amounts</HD>
                <P>In accordance with section 215(i) of the Act, for workers and family members for whom eligibility for benefits (that is, the worker's attainment of age 62, or disability or death before age 62) occurred before 2022, benefits will increase by 5.9 percent beginning with benefits for December 2021, which are payable in January 2022. For those first eligible after 2021, the 5.9 percent increase will not apply.</P>
                <P>For eligibility after 1978, we determine benefits using a formula provided by the Social Security Amendments of 1977 (Pub. L. 95-216), as described later in this notice.</P>
                <P>
                    For eligibility before 1979, we determine benefits by using a benefit table. The table is available on the internet at 
                    <E T="03">www.socialsecurity.gov/oact/ProgData/tableForm.html</E>
                     or by writing to: Social Security Administration, Office of Public Inquiries, Windsor Park Building, 6401 Security Boulevard, Baltimore, MD 21235.
                </P>
                <P>
                    Section 215(i)(2)(D) of the Act requires that, when we determine an increase in Social Security benefits, we will publish in the 
                    <E T="04">Federal Register</E>
                     a revision of the range of the PIAs and maximum family benefits based on the dollar amount and other provisions described in section 215(a)(1)(C)(i). We refer to these benefits as “special minimum” benefits. These benefits are payable to certain individuals with long periods of low earnings. To qualify for these benefits, an individual must have at least 11 years of coverage. To earn a year of coverage for purposes of the special minimum benefit, a person must earn at least a certain proportion of the old-law contribution and benefit base (described later in this notice). For years before 1991, the proportion is 25 percent; for years after 1990, it is 15 percent. In accordance with section 215(a)(1)(C)(i), the table below shows the revised range of PIAs and maximum family benefit amounts after the 5.9 percent benefit increase.
                </P>
                <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s25,7,9">
                    <TTITLE>Special Minimum PIAs and Maximum Family Benefits Payable for December 2021</TTITLE>
                    <BOXHD>
                        <CHED H="1">
                            Number of
                            <LI>years of</LI>
                            <LI>coverage</LI>
                        </CHED>
                        <CHED H="1">PIA</CHED>
                        <CHED H="1">
                            Maximum
                            <LI>family</LI>
                            <LI>benefit</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">11</ENT>
                        <ENT>$45.50</ENT>
                        <ENT>$69.40</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">12</ENT>
                        <ENT>93.10</ENT>
                        <ENT>141.10</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">13</ENT>
                        <ENT>140.90</ENT>
                        <ENT>212.80</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">14</ENT>
                        <ENT>188.30</ENT>
                        <ENT>284.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">15</ENT>
                        <ENT>235.60</ENT>
                        <ENT>355.10</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">16</ENT>
                        <ENT>283.60</ENT>
                        <ENT>426.80</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">17</ENT>
                        <ENT>331.20</ENT>
                        <ENT>498.80</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">18</ENT>
                        <ENT>378.80</ENT>
                        <ENT>569.90</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">19</ENT>
                        <ENT>426.40</ENT>
                        <ENT>641.50</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">20</ENT>
                        <ENT>474.30</ENT>
                        <ENT>712.40</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21</ENT>
                        <ENT>521.90</ENT>
                        <ENT>784.70</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">22</ENT>
                        <ENT>569.20</ENT>
                        <ENT>855.70</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">23</ENT>
                        <ENT>617.70</ENT>
                        <ENT>928.50</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">24</ENT>
                        <ENT>665.20</ENT>
                        <ENT>999.20</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">25</ENT>
                        <ENT>712.40</ENT>
                        <ENT>1,070.20</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">26</ENT>
                        <ENT>760.90</ENT>
                        <ENT>1,142.70</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">27</ENT>
                        <ENT>807.90</ENT>
                        <ENT>1,214.10</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">28</ENT>
                        <ENT>855.50</ENT>
                        <ENT>1,285.20</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">29</ENT>
                        <ENT>903.30</ENT>
                        <ENT>1,357.30</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">30</ENT>
                        <ENT>950.80</ENT>
                        <ENT>1,427.90</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD2">Title XVI Payment Amounts</HD>
                <P>In accordance with section 1617 of the Act, the Federal benefit rates used in computing Federal SSI payments for the aged, blind, and disabled will increase by 5.9 percent effective January 2022. For 2021, we derived the monthly payment amounts for an eligible individual, an eligible individual with an eligible spouse, and for an essential person—$794, $1,191, and $397, respectively—from yearly, unrounded Federal SSI payment amounts of $9,530.12, $14,293.61, and $4,775.99. For 2022, these yearly unrounded amounts respectively increase by 5.9 percent to $10,092.40, $15,136.93, and $5,057.77. We must round each of these resulting amounts, when not a multiple of $12, to the next lower multiple of $12. Therefore, the annual amounts, effective for 2022, are $10,092, $15,132, and $5,052. Dividing the yearly amounts by 12 gives the respective monthly amounts for 2022—$841, $1,261, and $421. For an eligible individual with an eligible spouse, we equally divide the amount payable between the two spouses.</P>
                <HD SOURCE="HD2">Title VIII Benefit Amount</HD>
                <P>Title VIII of the Act provides for special benefits to certain World War II veterans who reside outside the United States. Section 805 of the Act provides that “[t]he benefit under this title payable to a qualified individual for any month shall be in an amount equal to 75 percent of the Federal benefit rate [the maximum amount for an eligible individual] under title XVI for the month, reduced by the amount of the qualified individual's benefit income for the month.” Therefore, the monthly benefit for 2022 under this provision is 75 percent of $841, or $630.75.</P>
                <HD SOURCE="HD2">Student Earned Income Exclusion</HD>
                <P>A blind or disabled child who is a student regularly attending school, college, university, or a course of vocational or technical training can have limited earnings that do not count against his or her SSI payments. The maximum amount of such income that we may exclude in 2021 is $1,930 per month, but not more than $7,770 in all of 2021. These amounts increase based on a formula set forth in regulation 20 CFR 416.1112.</P>
                <P>To compute each of the monthly and yearly maximum amounts for 2022, we increase the unrounded amount for 2021 by the latest cost-of-living increase. If the amount so calculated is not a multiple of $10, we round it to the nearest multiple of $10. The unrounded monthly amount for 2021 is $1,928.19. We increase this amount by 5.9 percent to $2,041.95, which we then round to $2,040. Similarly, we increase the unrounded yearly amount for 2021, $7,772.50, by 5.9 percent to $8,231.08 and round this to $8,230. Therefore, the maximum amount of the income exclusion applicable to a student in 2022 is $2,040 per month but not more than $8,230 in all of 2022.</P>
                <HD SOURCE="HD2">Fee for Services Performed as a Representative Payee</HD>
                <P>Sections 205(j)(4)(A)(i) and 1631(a)(2)(D)(i) of the Act permit a qualified organization to collect a monthly fee from a beneficiary for expenses incurred in providing services as the beneficiary's representative payee. In 2021, the fee is limited to the lesser of: (1) 10 percent of the monthly benefit involved; or (2) $45 each month ($84 each month when the beneficiary is entitled to disability benefits and has an alcoholism or drug addiction condition that makes the individual incapable of managing such benefits). The dollar fee limits are subject to increase by the cost-of-living increase, with the resulting amounts rounded to the nearest whole dollar amount. Therefore, we increase the current amounts by 5.9 percent to $48 and $89 for 2022.</P>
                <HD SOURCE="HD2">Appointed Representative Fee Assessment</HD>
                <P>
                    Under sections 206(d) and 1631(d) of the Act, whenever we pay a fee to a representative such as an attorney, agent, or other person who represents claimants, we must impose on the representative an assessment to cover administrative costs. The assessment is no more than 6.3 percent of the representative's authorized fee or, if lower, a dollar amount that is subject to increase by the cost-of-living increase. We derive the dollar limit for December 2021 by increasing the unrounded limit for December 2020, $98.71, by 5.9 
                    <PRTPAGE P="58718"/>
                    percent, which is $104.53. We then round $104.53 to the next lower multiple of $1. The dollar limit effective for December 2021 is, therefore, $104.
                </P>
                <HD SOURCE="HD1">National Average Wage Index for 2020</HD>
                <HD SOURCE="HD2">Computation</HD>
                <P>
                    We determined the national average wage index for calendar year 2020 based on the 2019 national average wage index of $54,099.99, published in the 
                    <E T="04">Federal Register</E>
                     on October 22, 2020 (85 FR 67413), and the percentage increase in average wages from 2019 to 2020, as measured by annual wage data. We tabulate the annual wage data, including contributions to deferred compensation plans, as required by section 209(k) of the Act. The average amounts of wages calculated from these data were $51,916.27 for 2019 and $53,383.18 for 2020. To determine the national average wage index for 2020 at a level consistent with the national average wage indexing series for 1951 through 1977 (published December 29, 1978, at 43 FR 61016), we multiply the 2019 national average wage index of $54,099.99 by the percentage increase in average wages from 2019 to 2020 (based on SSA-tabulated wage data) as follows. We round the result to the nearest cent.
                </P>
                <HD SOURCE="HD2">National Average Wage Index Amount</HD>
                <P>Multiplying the national average wage index for 2019 ($54,099.99) by the ratio of the average wage for 2020 ($53,383.18) to that for 2019 ($51,916.27) produces the 2020 index, $55,628.60. The national average wage index for calendar year 2020 is about 2.83 percent higher than the 2019 index.</P>
                <HD SOURCE="HD1">Program Amounts That Change Based on the National Average Wage Index</HD>
                <P>Under the Act, the following amounts change with annual changes in the national average wage index: (1) The OASDI contribution and benefit base; (2) the exempt amounts under the retirement earnings test; (3) the dollar amounts, or bend points, in the PIA formula; (4) the bend points in the maximum family benefit formula; (5) the earnings required to credit a worker with a quarter of coverage; (6) the old-law contribution and benefit base (as determined under section 230 of the Act as in effect before the 1977 amendments); (7) the substantial gainful activity (SGA) amount applicable to statutorily blind individuals; and (8) the coverage threshold for election officials and election workers. Additionally, under section 3121(x) of the Internal Revenue Code, the domestic employee coverage threshold is based on changes in the national average wage index.</P>
                <P>Two amounts also increase under regulatory requirements—the SGA amount applicable to non-blind disabled persons, and the monthly earnings threshold that establishes a month as part of a trial work period for disabled beneficiaries.</P>
                <HD SOURCE="HD1">OASDI Contribution and Benefit Base</HD>
                <HD SOURCE="HD2">General</HD>
                <P>The OASDI contribution and benefit base is $147,000 for remuneration paid in 2022 and self-employment income earned in taxable years beginning in 2022. The OASDI contribution and benefit base serves as the maximum annual earnings on which OASDI taxes are paid. It is also the maximum annual earnings used in determining a person's OASDI benefits.</P>
                <HD SOURCE="HD2">Computation</HD>
                <P>Section 230(b) of the Act provides the formula used to determine the OASDI contribution and benefit base. Under the formula, the base for 2022 is the larger of: (1) The 1994 base of $60,600 multiplied by the ratio of the national average wage index for 2020 to that for 1992; or (2) the current base ($142,800). If the resulting amount is not a multiple of $300, we round it to the nearest multiple of $300.</P>
                <HD SOURCE="HD2">OASDI Contribution and Benefit Base Amount</HD>
                <P>Multiplying the 1994 OASDI contribution and benefit base ($60,600) by the ratio of the national average wage index for 2020 ($55,628.60 as determined above) to that for 1992 ($22,935.42) produces $146,981.97. We round this amount to $147,000. Because $147,000 exceeds the current base amount of $142,800, the OASDI contribution and benefit base is $147,000 for 2022.</P>
                <HD SOURCE="HD1">Retirement Earnings Test Exempt Amounts</HD>
                <HD SOURCE="HD2">General</HD>
                <P>We withhold Social Security benefits when a beneficiary under the NRA has earnings over the applicable retirement earnings test exempt amount. The NRA is the age when retirement benefits (before rounding) are equal to the PIA. The NRA is age 66 for those born in 1943-54, and it gradually increases to age 67 for those born in 1960 or later. A higher exempt amount applies in the year in which a person attains NRA, but only for earnings in months before such attainment. A lower exempt amount applies at all other ages below NRA. Section 203(f)(8)(B) of the Act provides formulas for determining the monthly exempt amounts. The annual exempt amounts are exactly 12 times the monthly amounts.</P>
                <P>For beneficiaries who attain NRA in the year, we withhold $1 in benefits for every $3 of earnings over the annual exempt amount for months before NRA. For all other beneficiaries under NRA, we withhold $1 in benefits for every $2 of earnings over the annual exempt amount.</P>
                <HD SOURCE="HD2">Computation</HD>
                <P>Under the formula that applies to beneficiaries attaining NRA after 2022, the lower monthly exempt amount for 2022 is the larger of: (1) The 1994 monthly exempt amount multiplied by the ratio of the national average wage index for 2020 to that for 1992; or (2) the 2021 monthly exempt amount ($1,580). If the resulting amount is not a multiple of $10, we round it to the nearest multiple of $10.</P>
                <P>Under the formula that applies to beneficiaries attaining NRA in 2022, the higher monthly exempt amount for 2022 is the larger of: (1) The 2002 monthly exempt amount multiplied by the ratio of the national average wage index for 2020 to that for 2000; or (2) the 2021 monthly exempt amount ($4,210). If the resulting amount is not a multiple of $10, we round it to the nearest multiple of $10.</P>
                <HD SOURCE="HD2">Lower Exempt Amount</HD>
                <P>Multiplying the 1994 retirement earnings test monthly exempt amount of $670 by the ratio of the national average wage index for 2020 ($55,628.60) to that for 1992 ($22,935.42) produces $1,625.05. We round this to $1,630. Because $1,630 exceeds the current exempt amount of $1,580, the lower retirement earnings test monthly exempt amount is $1,630 for 2022. The lower annual exempt amount is $19,560 under the retirement earnings test.</P>
                <HD SOURCE="HD2">Higher Exempt Amount</HD>
                <P>Multiplying the 2002 retirement earnings test monthly exempt amount of $2,500 by the ratio of the national average wage index for 2020 ($55,628.60) to that for 2000 ($32,154.82) produces $4,325.06. We round this to $4,330. Because $4,330 exceeds the current exempt amount of $4,210, the higher retirement earnings test monthly exempt amount is $4,330 for 2022. The higher annual exempt amount is $51,960 under the retirement earnings test.</P>
                <HD SOURCE="HD1">Primary Insurance Amount Formula</HD>
                <HD SOURCE="HD2">General</HD>
                <P>
                    The Social Security Amendments of 1977 provided a method for computing benefits that generally applies when a 
                    <PRTPAGE P="58719"/>
                    worker first becomes eligible for benefits after 1978. This method uses the worker's average indexed monthly earnings (AIME) to compute the PIA. We adjust the formula each year to reflect changes in general wage levels, as measured by the national average wage index.
                </P>
                <P>We also adjust, or index, a worker's earnings to reflect the change in the general wage levels that occurred during the worker's years of employment. Such indexing ensures that a worker's future benefit level will reflect the general rise in the standard of living that will occur during his or her working lifetime. To compute the AIME, we first determine the required number of years of earnings. We then select the number of years with the highest indexed earnings, add the indexed earnings for those years, and divide the total amount by the total number of months in those years. We then round the resulting average amount down to the next lower dollar amount. The result is the AIME.</P>
                <HD SOURCE="HD2">Computing the PIA</HD>
                <P>The PIA is the sum of three separate percentages of portions of the AIME. In 1979 (the first year the formula was in effect), these portions were the first $180, the amount between $180 and $1,085, and the amount over $1,085. We call the dollar amounts in the formula governing the portions of the AIME the bend points of the formula. Therefore, the bend points for 1979 were $180 and $1,085.</P>
                <P>To obtain the bend points for 2022, we multiply each of the 1979 bend-point amounts by the ratio of the national average wage index for 2020 to that average for 1977. We then round these results to the nearest dollar. Multiplying the 1979 amounts of $180 and $1,085 by the ratio of the national average wage index for 2020 ($55,628.60) to that for 1977 ($9,779.44) produces the amounts of $1,023.90 and $6,171.83. We round these to $1,024 and $6,172. Therefore, the portions of the AIME to be used in 2022 are the first $1,024, the amount between $1,024 and $6,172, and the amount over $6,172.</P>
                <P>Therefore, for individuals who first become eligible for old-age insurance benefits or disability insurance benefits in 2022, or who die in 2022 before becoming eligible for benefits, their PIA will be the sum of:</P>
                <P>(a) 90 percent of the first $1,024 of their AIME, plus</P>
                <P>(b) 32 percent of their AIME over $1,024 and through $6,172, plus</P>
                <P>(c) 15 percent of their AIME over $6,172.</P>
                <P>We round this amount to the next lower multiple of $0.10 if it is not already a multiple of $0.10. This formula and the rounding adjustment are stated in section 215(a) of the Act.</P>
                <HD SOURCE="HD1">Maximum Benefits Payable to a Family</HD>
                <HD SOURCE="HD2">General</HD>
                <P>The 1977 amendments continued the policy of limiting the total monthly benefits that a worker's family may receive based on the worker's PIA. Those amendments also continued the relationship between maximum family benefits and PIAs but changed the method of computing the maximum benefits that may be paid to a worker's family. The Social Security Disability Amendments of 1980 (Pub. L. 96-265) established a formula for computing the maximum benefits payable to the family of a disabled worker. This formula applies to the family benefits of workers who first become entitled to disability insurance benefits after June 30, 1980, and who first become eligible for these benefits after 1978. For disabled workers initially entitled to disability benefits before July 1980 or whose disability began before 1979, we compute the family maximum payable the same as the old-age and survivor family maximum.</P>
                <HD SOURCE="HD2">Computing the Old-Age and Survivor Family Maximum</HD>
                <P>The formula used to compute the family maximum is similar to that used to compute the PIA. It involves computing the sum of four separate percentages of portions of the worker's PIA. In 1979, these portions were the first $230, the amount between $230 and $332, the amount between $332 and $433, and the amount over $433. We refer to such dollar amounts in the formula as the bend points of the family-maximum formula.</P>
                <P>To obtain the bend points for 2022, we multiply each of the 1979 bend-point amounts by the ratio of the national average wage index for 2020 to that average for 1977. Then we round this amount to the nearest dollar. Multiplying the amounts of $230, $332, and $433 by the ratio of the national average wage index for 2020 ($55,628.60) to that for 1977 ($9,779.44) produces the amounts of $1,308.31, $1,888.52, and $2,463.04. We round these amounts to $1,308, $1,889, and $2,463. Therefore, the portions of the PIAs to be used in 2022 are the first $1,308, the amount between $1,308 and $1,889, the amount between $1,889 and $2,463, and the amount over $2,463.</P>
                <P>Thus, for the family of a worker who becomes age 62 or dies in 2022 before age 62, we will compute the total benefits payable to them so that it does not exceed:</P>
                <P>(a) 150 percent of the first $1,308 of the worker's PIA, plus</P>
                <P>(b) 272 percent of the worker's PIA over $1,308 through $1,889, plus</P>
                <P>(c) 134 percent of the worker's PIA over $1,889 through $2,463, plus</P>
                <P>(d) 175 percent of the worker's PIA over $2,463.</P>
                <P>We then round this amount to the next lower multiple of $0.10 if it is not already a multiple of $0.10. This formula and the rounding adjustment are stated in section 203(a) of the Act.</P>
                <HD SOURCE="HD1">Quarter of Coverage Amount</HD>
                <HD SOURCE="HD2">General</HD>
                <P>The earnings required for a quarter of coverage in 2022 is $1,510. A quarter of coverage is the basic unit for determining if a worker is insured under the Social Security program. For years before 1978, we generally credited an individual with a quarter of coverage for each quarter in which wages of $50 or more were paid, or with 4 quarters of coverage for every taxable year in which $400 or more of self-employment income was earned. Beginning in 1978, employers generally report wages yearly instead of quarterly. With the change to yearly reporting, section 352(b) of the Social Security Amendments of 1977 amended section 213(d) of the Act to provide that a quarter of coverage would be credited for each $250 of an individual's total wages and self-employment income for calendar year 1978, up to a maximum of 4 quarters of coverage for the year. The amendment also provided a formula for years after 1978.</P>
                <HD SOURCE="HD2">Computation</HD>
                <P>Under the prescribed formula, the quarter of coverage amount for 2022 is the larger of: (1) The 1978 amount of $250 multiplied by the ratio of the national average wage index for 2020 to that for 1976; or (2) the current amount of $1,470. Section 213(d) provides that if the resulting amount is not a multiple of $10, we round it to the nearest multiple of $10.</P>
                <HD SOURCE="HD2">Quarter of Coverage Amount</HD>
                <P>
                    Multiplying the 1978 quarter of coverage amount ($250) by the ratio of the national average wage index for 2020 ($55,628.60) to that for 1976 ($9,226.48) produces $1,507.31. We then round this amount to $1,510. Because $1,510 exceeds the current amount of $1,470, the quarter of coverage amount is $1,510 for 2022.
                    <PRTPAGE P="58720"/>
                </P>
                <HD SOURCE="HD1">Old-Law Contribution and Benefit Base</HD>
                <HD SOURCE="HD2">General</HD>
                <P>The old-law contribution and benefit base for 2022 is $109,200. This base would have been effective under the Act without the enactment of the 1977 amendments.</P>
                <P>The old-law contribution and benefit base is used by:</P>
                <P>(a) The Railroad Retirement program to determine certain tax liabilities and tier II benefits payable under that program to supplement the tier I payments that correspond to basic Social Security benefits,</P>
                <P>(b) the Pension Benefit Guaranty Corporation to determine the maximum amount of pension guaranteed under the Employee Retirement Income Security Act (section 230(d) of the Act),</P>
                <P>(c) Social Security to determine a year of coverage in computing the special minimum benefit, as described earlier, and</P>
                <P>(d) Social Security to determine a year of coverage (acquired whenever earnings equal or exceed 25 percent of the old-law base for this purpose only) in computing benefits for persons who are also eligible to receive pensions based on employment not covered under section 210 of the Act.</P>
                <HD SOURCE="HD2">Computation</HD>
                <P>The old-law contribution and benefit base is the larger of: (1) The 1994 old-law base ($45,000) multiplied by the ratio of the national average wage index for 2020 to that for 1992; or (2) the current old-law base ($106,200). If the resulting amount is not a multiple of $300, we round it to the nearest multiple of $300.</P>
                <HD SOURCE="HD2">Old-Law Contribution and Benefit Base Amount</HD>
                <P>Multiplying the 1994 old-law contribution and benefit base ($45,000) by the ratio of the national average wage index for 2020 ($55,628.60) to that for 1992 ($22,935.42) produces $109,145.03. We round this amount to $109,200. Because $109,200 exceeds the current amount of $106,200, the old-law contribution and benefit base is $109,200 for 2022.</P>
                <HD SOURCE="HD1">Substantial Gainful Activity Amounts</HD>
                <HD SOURCE="HD2">General</HD>
                <P>A finding of disability under titles II and XVI of the Act requires that a person, except for a title XVI disabled child, be unable to engage in SGA. A person who is earning more than a certain monthly amount is ordinarily considered to be engaging in SGA. The monthly earnings considered as SGA depends on the nature of a person's disability. Section 223(d)(4)(A) of the Act specifies the SGA amount for statutorily blind individuals under title II while our regulations (20 CFR 404.1574 and 416.974) specify the SGA amount for non-blind individuals.</P>
                <HD SOURCE="HD2">Computation</HD>
                <P>The monthly SGA amount for statutorily blind individuals under title II for 2022 is the larger of: (1) The amount for 1994 multiplied by the ratio of the national average wage index for 2020 to that for 1992; or (2) the amount for 2021. The monthly SGA amount for non-blind disabled individuals for 2022 is the larger of: (1) The amount for 2000 multiplied by the ratio of the national average wage index for 2020 to that for 1998; or (2) the amount for 2021. In either case, if the resulting amount is not a multiple of $10, we round it to the nearest multiple of $10.</P>
                <HD SOURCE="HD2">SGA Amount for Statutorily Blind Individuals</HD>
                <P>Multiplying the 1994 monthly SGA amount for statutorily blind individuals ($930) by the ratio of the national average wage index for 2020 ($55,628.60) to that for 1992 ($22,935.42) produces $2,255.66. We then round this amount to $2,260. Because $2,260 exceeds the current amount of $2,190, the monthly SGA amount for statutorily blind individuals is $2,260 for 2022.</P>
                <HD SOURCE="HD2">SGA Amount for Non-Blind Disabled Individuals</HD>
                <P>Multiplying the 2000 monthly SGA amount for non-blind individuals ($700) by the ratio of the national average wage index for 2020 ($55,628.60) to that for 1998 ($28,861.44) produces $1,349.21. We then round this amount to $1,350. Because $1,350 exceeds the current amount of $1,310, the monthly SGA amount for non-blind disabled individuals is $1,350 for 2022.</P>
                <HD SOURCE="HD1">Trial Work Period Earnings Threshold</HD>
                <HD SOURCE="HD2">General</HD>
                <P>During a trial work period of 9 months in a rolling 60-month period, a beneficiary receiving Social Security disability benefits may test his or her ability to work and still receive monthly benefit payments. To be considered a trial work period month, earnings must be over a certain level. In 2022, any month in which earnings exceed $970 is considered a month of services for an individual's trial work period.</P>
                <HD SOURCE="HD2">Computation</HD>
                <P>The method used to determine the new amount is set forth in our regulations at 20 CFR 404.1592(b). Monthly earnings in 2022, used to determine whether a month is part of a trial work period, is the larger of: (1) The amount for 2001 ($530) multiplied by the ratio of the national average wage index for 2020 to that for 1999; or (2) the amount for 2021. If the resulting amount is not a multiple of $10, we round it to the nearest multiple of $10.</P>
                <HD SOURCE="HD2">Trial Work Period Earnings Threshold Amount</HD>
                <P>Multiplying the 2001 monthly earnings threshold ($530) by the ratio of the national average wage index for 2020 ($55,628.60) to that for 1999 ($30,469.84) produces $967.62. We then round this amount to $970. Because $970 exceeds the current amount of $940, the monthly earnings threshold is $970 for 2022.</P>
                <HD SOURCE="HD1">Domestic Employee Coverage Threshold</HD>
                <HD SOURCE="HD2">General</HD>
                <P>The minimum amount a domestic worker must earn so that such earnings are covered under Social Security or Medicare is the domestic employee coverage threshold. For 2022, this threshold is $2,400. Section 3121(x) of the Internal Revenue Code provides the formula for increasing the threshold.</P>
                <HD SOURCE="HD2">Computation</HD>
                <P>Under the formula, the domestic employee coverage threshold for 2022 is equal to the 1995 amount of $1,000 multiplied by the ratio of the national average wage index for 2020 to that for 1993. If the resulting amount is not a multiple of $100, we round it to the next lower multiple of $100.</P>
                <HD SOURCE="HD2">Domestic Employee Coverage Threshold Amount</HD>
                <P>Multiplying the 1995 domestic employee coverage threshold ($1,000) by the ratio of the national average wage index for 2020 ($55,628.60) to that for 1993 ($23,132.67) produces $2,404.76. We then round this amount to $2,400. Therefore, the domestic employee coverage threshold amount is $2,400 for 2022.</P>
                <HD SOURCE="HD1">Election Official and Election Worker Coverage Threshold</HD>
                <HD SOURCE="HD2">General</HD>
                <P>
                    The minimum amount an election official and election worker must earn so the earnings are covered under Social Security or Medicare is the election official and election worker coverage threshold. For 2022, this threshold is $2,000. Section 218(c)(8)(B) of the Act provides the formula for increasing the threshold.
                    <PRTPAGE P="58721"/>
                </P>
                <HD SOURCE="HD2">Computation</HD>
                <P>Under the formula, the election official and election worker coverage threshold for 2022 is equal to the 1999 amount of $1,000 multiplied by the ratio of the national average wage index for 2020 to that for 1997. If the amount we determine is not a multiple of $100, we round it to the nearest multiple of $100.</P>
                <HD SOURCE="HD2">Election Official and Election Worker Coverage Threshold Amount</HD>
                <P>Multiplying the 1999 coverage threshold amount ($1,000) by the ratio of the national average wage index for 2020 ($55,628.60) to that for 1997 ($27,426.00) produces $2,028.32. We then round this amount to $2,000. Therefore, the election official and election worker coverage threshold amount is $2,000 for 2022.</P>
                <EXTRACT>
                    <FP>(Catalog of Federal Domestic Assistance: Program Nos. 96.001 Social Security-Disability Insurance; 96.002 Social Security-Retirement Insurance; 96.004 Social Security-Survivors Insurance; 96.006 Supplemental Security Income)</FP>
                </EXTRACT>
                <P>
                    The Acting Commissioner of the Social Security Administration, Kilolo Kijakazi, having reviewed and approved this document, is delegating the authority to electronically sign this document to Faye I. Lipsky, who is the primary Federal Register Liaison for SSA, for purposes of publication in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <SIG>
                    <NAME>Faye I. Lipsky,</NAME>
                    <TITLE>Federal Register Liaison, Office of Legislation and Congressional Affairs, Social Security Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23031 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4191-02-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">SURFACE TRANSPORTATION BOARD</AGENCY>
                <DEPDOC>[Docket No. FD 36547]</DEPDOC>
                <SUBJECT>BNSF Railway Company—Trackage Rights Exemption—Union Pacific Railroad Company</SUBJECT>
                <P>BNSF Railway Company (BNSF), a Class I rail carrier, has filed a verified notice of exemption under 49 CFR 1180.2(d)(7) for overhead trackage rights over a rail line owned by Union Pacific Railroad Company (UP), specifically, UP's Jefferson City Subdivision, between milepost 34.66 near Pacific, Mo., and milepost 46.22 near Labadie, Mo. (the Line).</P>
                <P>
                    Pursuant to a written trackage rights agreement,
                    <SU>1</SU>
                    <FTREF/>
                     UP has agreed to grant overhead trackage rights to BNSF over the Line. According to the verified notice, the agreement is pursuant to the Restated and Amended BNSF Settlement Agreement (RASA) between BNSF and UP in connection with the transaction authorized in 
                    <E T="03">Union Pacific Corp.—Control &amp; Merger—Southern Pacific Rail Corp.,</E>
                     FD 32760, Decision No. 44 (STB served Aug. 12, 1996). The purpose of this transaction is to allow BNSF to serve Ameren Corporation's facility at Labadie as well as the right to serve all “2-to-1” Shipper Facilities, New Shipper Facilities, and Existing Transload Facilities at Labadie as those terms are defined in the RASA.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         A redacted version of the draft trackage rights agreement between UP and BNSF was filed with the verified notice. An unredacted version of the agreement was submitted to the Board under seal concurrently with a motion for protective order, which was granted on October 14, 2021. BNSF states that it will submit an executed copy of the agreement within 10 days of its execution, pursuant to 49 CFR 1180.6(a)(7)(ii).
                    </P>
                </FTNT>
                <P>The transaction may be consummated on November 6, 2021, the effective date of the exemption (30 days after the verified notice was filed).</P>
                <P>
                    As a condition to this exemption, any employees affected by the acquisition of the trackage rights will be protected by the conditions imposed in 
                    <E T="03">Norfolk &amp; Western Railway—Trackage Rights—Burlington Northern, Inc.,</E>
                     354 I.C.C. 605 (1978), as modified in 
                    <E T="03">Mendocino Coast Railway—Lease &amp; Operate—California Western Railroad,</E>
                     360 I.C.C. 653 (1980).
                </P>
                <P>If the 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 by October 29, 2021 (at least seven days before the exemption becomes effective).</P>
                <P>All pleadings, referring to Docket No. FD 36547, should be filed with the Surface Transportation Board via e-filing on the Board's website. In addition, a copy of each pleading must be served on BNSF's representative, Peter W. Denton, Steptoe &amp; Johnson LLP, 1330 Connecticut Avenue NW, Washington, DC 20036.</P>
                <P>According to BNSF, this action is categorically excluded from environmental review under 49 CFR 1105.6(c)(3) and from historic preservation reporting requirements under 49 CFR 1105.8(b)(3).</P>
                <P>
                    Board decisions and notices are available at 
                    <E T="03">www.stb.gov.</E>
                </P>
                <SIG>
                    <DATED>Decided: October 19, 2021.</DATED>
                    <P>By the Board, Scott M. Zimmerman, Acting Director, Office of Proceedings.</P>
                    <NAME>Eden Besera,</NAME>
                    <TITLE>Clearance Clerk.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23071 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4915-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Railroad Administration</SUBAGY>
                <DEPDOC>[Docket No. FRA-2021-0006-N-14]</DEPDOC>
                <SUBJECT>Proposed Agency Information Collection Activities; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Railroad Administration (FRA), U.S. Department of Transportation (DOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of information collection; request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Under the Paperwork Reduction Act of 1995 (PRA) and its implementing regulations, FRA seeks approval of the Information Collection Request (ICR) abstracted below. Before submitting this ICR to the Office of Management and Budget (OMB) for approval, FRA is soliciting public comment on specific aspects of the activities identified in the ICR.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested persons are invited to submit comments on or before December 21, 2021].</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for the proposed ICR should be submitted on 
                        <E T="03">regulations.gov</E>
                         to the docket, Docket No. FRA-2021-0006. All comments received will be posted without change to the docket, including any personal information provided. Please refer to the assigned OMB control number in any correspondence submitted. FRA will summarize comments received in response to this notice in a subsequent notice and include them in its information collection submission to OMB for approval.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ms. Hodan Wells, Information Collection Clearance Officer, at email: 
                        <E T="03">hodan.wells@dot.gov</E>
                         or telephone: (202) 493-0440.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The PRA, 44 U.S.C. 3501-3520, and its implementing regulations, 5 CFR part 1320, require Federal agencies to provide 60-days' notice to the public to allow comment on information collection activities before seeking OMB approval of the activities. 
                    <E T="03">See</E>
                     44 U.S.C. 3506, 3507; 5 CFR 1320.8 through 1320.12. Specifically, FRA invites interested parties to comment on the following ICR regarding: (1) Whether the 
                    <PRTPAGE P="58722"/>
                    information collection activities are necessary for FRA to properly execute its functions, including whether the activities will have practical utility; (2) the accuracy of FRA's estimates of the burden of the information collection activities, including the validity of the methodology and assumptions used to determine the estimates; (3) ways for FRA to enhance the quality, utility, and clarity of the information being collected; and (4) ways for FRA to minimize the burden of information collection activities on the public, including the use of automated collection techniques or other forms of information technology. 
                    <E T="03">See</E>
                     44 U.S.C. 3506(c)(2)(A); 5 CFR 1320.8(d)(1).
                </P>
                <P>
                    FRA believes that soliciting public comment may reduce the administrative and paperwork burdens associated with the collection of information that Federal regulations mandate. In summary, FRA reasons that comments received will advance three objectives: (1) Reduce reporting burdens; (2) organize information collection requirements in a “user-friendly” format to improve the use of such information; and (3) accurately assess the resources expended to retrieve and produce information requested. 
                    <E T="03">See</E>
                     44 U.S.C. 3501.
                </P>
                <P>The summary below describes the ICR that FRA will submit for OMB clearance as the PRA requires:</P>
                <P>
                    <E T="03">Title:</E>
                     Railroad Signal System.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     2130-0006.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The information collected under 49 CFR parts 233, 235, and 236 is used by FRA to monitor railroad compliance with FRA's inspection and testing requirements for signal systems, as well as to review and approve railroad requests to discontinue or materially modify existing signal systems. The information collected is also used by FRA to monitor signal failures (
                    <E T="03">e.g.,</E>
                     failure of a signal appliance, device, method, or system to function or indicate as required by 49 CFR part 236 that results in a more favorable aspect than intended or other condition hazardous to the movement of a train).
                </P>
                <P>For instance:</P>
                <P>• § 233.5 requires each railroad to report to FRA within 24 hours after learning of an accident or incident arising from signal failure.</P>
                <P>• § 233.7 requires each railroad to report signal failures within 15 days in accordance with the instructions printed on Form FRA F 6180.14.</P>
                <P>• § 235.5 requires railroads to apply for FRA approval to discontinue or materially modify railroad signal systems.</P>
                <P>• § 235.8 allows railroads to seek relief from the requirements in 49 CFR part 236.</P>
                <P>• § 235.20 describes the protest process, including essential information that must be included in the protest, the address for filing the protest, the time limit for filing the protest, and the requirement that a protestant requesting a public hearing explain why written statements cannot be used to explain his or her position.</P>
                <P>• § 236.110 requires that the results of signal system tests required under §§ 236.102-109; §§ 236.376-387; §§ 236.576-577; and §§ 236.586-589 be recorded on pre-printed forms provided by the railroad or by electronic means, subject to FRA approval.</P>
                <P>• Finally, § 236.590 requires railroads to clean and inspect the automatic train stop, train control, or cab signal pneumatic apparatus on locomotives and then record the results of the inspection as required by § 229.29(a).</P>
                <P>
                    <E T="03">Type of Request:</E>
                     Extension without change (with changes in estimates) of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Businesses.
                </P>
                <P>
                    <E T="03">Form(s):</E>
                     FRA F 6180.14.
                </P>
                <P>
                    <E T="03">Respondent Universe:</E>
                     754 railroads.
                </P>
                <P>
                    <E T="03">Frequency of Submission:</E>
                     On occasion. 
                </P>
                <P>
                    <E T="03">Reporting Burden:</E>
                </P>
                <GPOTABLE COLS="6" OPTS="L2,tp0,i1" CDEF="s150,r50,r50,r50,12,12">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">
                            CFR section 
                            <SU>1</SU>
                        </CHED>
                        <CHED H="1">
                            Respondent
                            <LI>universe</LI>
                        </CHED>
                        <CHED H="1">
                            Total annual
                            <LI>responses</LI>
                        </CHED>
                        <CHED H="1">
                            Average
                            <LI>time per</LI>
                            <LI>responses</LI>
                        </CHED>
                        <CHED H="1">
                            Total
                            <LI>annual</LI>
                            <LI>burden</LI>
                            <LI>hours</LI>
                        </CHED>
                        <CHED H="1">
                            Total cost
                            <LI>
                                equivalent 
                                <SU>2</SU>
                            </LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">233.5—Accidents resulting from signal failure—Telephone report to FRA</ENT>
                        <ENT>754 railroads</ENT>
                        <ENT>1 telephone call</ENT>
                        <ENT>30 minutes</ENT>
                        <ENT>0.50</ENT>
                        <ENT>$38.72</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">233.7—Signal failure reports—Form FRA F 6180.14 “False Proceed Signal Report“</ENT>
                        <ENT>754 railroads</ENT>
                        <ENT>10 reports</ENT>
                        <ENT>15 minutes</ENT>
                        <ENT>2.50</ENT>
                        <ENT>193.60</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">235.5—Changes requiring filing of application—Signal systems</ENT>
                        <ENT>80 railroads</ENT>
                        <ENT>24 applications</ENT>
                        <ENT>10 hours</ENT>
                        <ENT>240.00</ENT>
                        <ENT>18,585.60</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">235.8—Relief from the requirements of part 236 of this title</ENT>
                        <ENT>80 railroads</ENT>
                        <ENT>10 relief requests</ENT>
                        <ENT>10 hours</ENT>
                        <ENT>100.00</ENT>
                        <ENT>7,744.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">235.20—Protests—Protestant shall file with FRA against application for relief from part 236 requirements</ENT>
                        <ENT>Railroads and public</ENT>
                        <ENT>10 protest letters</ENT>
                        <ENT>30 minutes</ENT>
                        <ENT>5.00</ENT>
                        <ENT>387.20</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">236.110—Results of tests made in compliance with §§ 236.102-109; 236.376-387; 236.576; 236.577; 236.586-589; and 236.917(a)—Records</ENT>
                        <ENT>80 railroads</ENT>
                        <ENT>300,000 (paper records) + 636,660 (electronic records)</ENT>
                        <ENT>27 minutes (paper) + 8 minutes (electronic)</ENT>
                        <ENT>219,888.00</ENT>
                        <ENT>13,122,915.84</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="01">236.590—Pneumatic apparatus—Inspection, cleaning, and results of inspection—Record</ENT>
                        <ENT>18 railroads</ENT>
                        <ENT>6,697 stenciling or tags</ENT>
                        <ENT>22.50 minutes</ENT>
                        <ENT>2,511.38</ENT>
                        <ENT>180,543.11</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">
                            Total 
                            <SU>3</SU>
                        </ENT>
                        <ENT>754 railroads</ENT>
                        <ENT>943,412 responses</ENT>
                        <ENT>N/A</ENT>
                        <ENT>222,747</ENT>
                        <ENT>13,330,408</ENT>
                    </ROW>
                    <TNOTE>
                        <SU>1</SU>
                         The current inventory exhibits a total burden of 444,820 hours while the total burden of this notice is 222,747 hours. As part of its review of this ICR renewal, FRA determined some of the previous estimates were preliminary, outdated, or duplicative.
                    </TNOTE>
                    <TNOTE>
                        <SU>2</SU>
                         The dollar equivalent cost is derived from the Surface Transportation Board's 2020 Full Year Wage A&amp;B data series using the appropriate employee group hourly wage rate that includes a 75-percent overhead charge.
                    </TNOTE>
                    <TNOTE>
                        <SU>3</SU>
                         Totals may not add due to rounding.
                    </TNOTE>
                </GPOTABLE>
                <P>
                    <E T="03">Total Estimated Annual Responses:</E>
                     943,412.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Burden:</E>
                     222,747 hours.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Burden Hour Dollar Cost Equivalent:</E>
                     $13,330,408.
                </P>
                <P>
                    Under 44 U.S.C. 3507(a) and 5 CFR 1320.5(b) and 1320.8(b)(3)(vi), FRA informs all interested parties that a respondent is not required to respond to, conduct, or sponsor a collection of 
                    <PRTPAGE P="58723"/>
                    information that does not display a currently valid OMB control number.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     44 U.S.C. 3501-3520.
                </P>
                <SIG>
                    <NAME>Brett A. Jortland,</NAME>
                    <TITLE>Deputy Chief Counsel.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23104 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-06-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Transit Administration</SUBAGY>
                <DEPDOC>[FTA Docket No. FTA 2021-0015]</DEPDOC>
                <SUBJECT>Agency Information Collection Activity Under OMB Review</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Transit Administration, DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the Federal Transit Administration (FTA) to request the Office of Management and Budget (OMB) to approve the extension of a currently approved information collection.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be submitted before December 21, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>To ensure that your comments are not entered more than once into the docket, submit comments identified by the docket number by only one of the following methods:</P>
                    <P>
                        1. 
                        <E T="03">Website: www.regulations.gov.</E>
                         Follow the instructions for submitting comments on the U.S. Government electronic docket site. (Note: The U.S. Department of Transportation's (DOT's) electronic docket is no longer accepting electronic comments.) All electronic submissions must be made to the U.S. Government electronic docket site at 
                        <E T="03">www.regulations.gov.</E>
                         Commenters should follow the directions below for mailed and hand-delivered comments.
                    </P>
                    <P>
                        2. 
                        <E T="03">Fax:</E>
                         202-366-7951.
                    </P>
                    <P>
                        3. 
                        <E T="03">Mail:</E>
                         U.S. Department of Transportation, 1200 New Jersey Avenue SE, Docket Operations, M-30, West Building, Ground Floor, Room W12-140, Washington, DC 20590-0001.
                    </P>
                    <P>
                        4. 
                        <E T="03">Hand Delivery:</E>
                         U.S. Department of Transportation, 1200 New Jersey Avenue SE, Docket Operations, M-30, West Building, Ground Floor, Room W12-140, Washington, DC 20590-0001 between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         You must include the agency name and docket number for this notice at the beginning of your comments. Submit two copies of your comments if you submit them by mail. For confirmation that FTA has received your comments, include a self-addressed stamped postcard. Note that all comments received, including any personal information, will be posted and will be available to internet users, without change, to 
                        <E T="03">www.regulations.gov.</E>
                         You may review DOT's complete Privacy Act Statement in the 
                        <E T="04">Federal Register</E>
                         published April 11, 2000, (65 FR 19477), or you may visit 
                        <E T="03">www.regulations.gov.</E>
                         Docket: For access to the docket to read background documents and comments received, go to 
                        <E T="03">www.regulations.gov</E>
                         at any time. Background documents and comments received may also be viewed at the U.S. Department of Transportation, 1200 New Jersey Avenue SE, Docket Operations, M-30, West Building, Ground Floor, Room W12-140, Washington, DC 20590-0001 between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Tawanna Glover (202) 493-0229 or email: 
                        <E T="03">Tawanna.Glover@dot.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Interested parties are invited to send comments regarding any aspect of this information collection, including: (1) The necessity and utility of the information collection for the proper performance of the functions of the FTA; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the collected information; and (4) ways to minimize the collection burden without reducing the quality of the collected information. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection.</P>
                <P>
                    <E T="03">Title:</E>
                     49 U.S.C. Section 5320 Paul S. Sarbanes Transit in Parks Program (OMB Number: 2132-0574).
                </P>
                <P>
                    <E T="03">Background:</E>
                     Section 3021 of the Safe, Accountable, Flexible, Efficient Transportation Equity Act—A Legacy for Users (SAFETEA-LU), as amended, established the Paul S. Sarbanes Transit in Parks Program (Transit in Parks Program—49 U.S.C. 5320). The program was administered by FTA in partnership with the Department of the Interior (DOI) and the U.S. Department of Agriculture's Forest Service. The program provided grants to Federal land management agencies that manage an eligible area, including but not limited to the National Park Service, the Fish and Wildlife Service, the Bureau of Land Management, the Forest Service, the Bureau of Reclamation; and State, tribal and local governments with jurisdiction over land in the vicinity of an eligible area, acting with the consent of a Federal land management agency, alone or in partnership with a Federal land management agency or other governmental or non-governmental participant. The purpose of the program was to provide for the planning and capital costs of alternative transportation systems that will enhance the protection of national parks and Federal lands; increase the enjoyment of visitors' experience by conserving natural, historical, and cultural resources; reduce congestion and pollution; improve visitor mobility and accessibility; enhance visitor experience; and ensure access to all, including persons with disabilities. The Paul S. Sarbanes Transit in the Parks program was repealed under the Moving Ahead for Progress in the 21st Century Act (MAP-21). However, funding previously authorized for programs repealed by MAP-21 remain available for their originally authorized purposes until the period of availability expires, the funds are fully expended, the funds are rescinded by Congress, or the funds are otherwise reallocated.
                </P>
                <P>
                    <E T="03">Respondents:</E>
                     Transit agencies, States, and Metropolitan Planning Organizations.
                </P>
                <P>
                    <E T="03">Estimated Annual Burden on Respondents:</E>
                     Approximately 2 hours for each of the 2 remaining respondents.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden:</E>
                     4 hours.
                </P>
                <P>
                    <E T="03">Estimated Total Burden Cost:</E>
                     $255.32.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     Annually.
                </P>
                <SIG>
                    <NAME>Nadine Pembleton,</NAME>
                    <TITLE>Director Office of Management Planning.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23065 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE TREASURY</AGENCY>
                <SUBAGY>Office of the Comptroller of the Currency</SUBAGY>
                <SUBJECT>Agency Information Collection Activities: Information Collection Renewal; Comment Request; Libor Self-Assessment</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of the Comptroller of the Currency (OCC), Treasury. ACTION: Notice and request for comment.</P>
                </AGY>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The OCC, 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 a new information collection as required by the Paperwork Reduction Act of 1995 (PRA). In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and the respondent is not required to respond to, an information 
                        <PRTPAGE P="58724"/>
                        collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is soliciting comment concerning renewal of a collection of information titled, “Libor Self-Assessment.”
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be submitted on or before December 21, 2021. </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Commenters are encouraged to submit comments by email, if possible. You may submit comments by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Email: prainfo@occ.treas.gov.</E>
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Chief Counsel's Office, Attention: Comment Processing, Office of the Comptroller of the Currency, Attention: 1557-0349, 400 7th Street SW, Suite 3E-218, Washington, DC 20219.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery/Courier:</E>
                         400 7th Street SW, Suite 3E-218, Washington, DC 20219.
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         (571) 465-4326.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         You must include “OCC” as the agency name and “1557-0349” in your comment. In general, the OCC will publish comments on 
                        <E T="03">www.reginfo.gov</E>
                         without change, including any business or personal information provided, such as name and address information, email addresses, or phone numbers. 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.
                    </P>
                    <P>Following the close of this notice's 60-day comment period, the OCC will publish a second notice with a 30-day comment period. You may review comments and other related materials that pertain to this information collection beginning on the date of publication of the second notice for this collection by the method set forth in the next bullet.</P>
                    <P>
                        • 
                        <E T="03">Viewing Comments Electronically:</E>
                         Go to 
                        <E T="03">www.reginfo.gov.</E>
                         Hover over the “Information Collection Review” tab. Underneath the “Currently under Review” section heading, from the drop-down menu select “Department of Treasury” and then click “submit.” This information collection can be located by searching by OMB control number “1557-0349” or “Libor Self-Assessment.” Upon finding the appropriate information collection, click on the related “ICR Reference Number.” On the next screen, select “View Supporting Statement and Other Documents” and then click on the link to any comment listed at the bottom of the screen.
                    </P>
                    <P>
                        • For assistance in navigating 
                        <E T="03">www.reginfo.gov,</E>
                         please contact the Regulatory Information Service Center at (202) 482-7340.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Shaquita Merritt, Clearance Officer, (202) 649-5490, Chief Counsel's Office, Office of the Comptroller of the Currency, 400 7th Street SW, Washington, DC 20219.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the OMB for each collection of information that they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) to include 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 title 44 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 renewal of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, the OCC is publishing notice of the renewal of the collection of information set forth in this document, which was approved on an emergency basis.
                </P>
                <P>
                    <E T="03">Title:</E>
                     Libor Self-Assessment.
                </P>
                <P>
                    <E T="03">OMB Control No.:</E>
                     1557-0349. 
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Regular. 
                </P>
                <P>
                    <E T="03">Description:</E>
                     The expected cessation of the London InterBank Offered Rate (Libor) prompted the OCC to create a self-assessment tool for banks to use in preparing for the expected Libor cessation. The self-assessment tool may be used in assessing the appropriateness of a bank's Libor transition plan, the execution of the plan by its management, and related matters.
                </P>
                <P>
                    The Intercontinental Exchange Libor is a reference rate that is intended to reflect the cost of unsecured interbank borrowing. Libor is published daily in five currencies with seven maturities ranging from overnight to 12 months. It is used globally in the over-the-counter derivatives market, bonds, loan products, and securitizations. As of the end of 2020, $223 trillion of financial instruments were exposed to U.S. dollar (USD) Libor as the primary reference rate.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">https://www.newyorkfed.org/medialibrary/Microsites/arrc/files/2021/USD-LIBOR-transition-progress-report-mar-21.pdf.</E>
                    </P>
                </FTNT>
                <P>While certain reference rates have ceased to be reported in the past, the significant exposure of the financial markets to Libor creates the need for banks to assess whether they are identifying applicable risks, preparing for Libor cessation, and successfully transitioning to replacement reference rates. Libor is referenced globally, and its cessation could affect banks of all sizes through direct or indirect exposure.</P>
                <P>There is risk of market disruptions, litigation, and destabilized balance sheets if acceptable replacement rates do not attract sufficient market-wide acceptance or if contracts cannot seamlessly transition to new rates. A bank's risk exposure from expected Libor cessation depends on the bank's specific circumstances. Many community banks may not offer products or services that use Libor. However, community banks could have Libor exposure in positions such as Federal Home Loan Bank (FHLB) borrowings, mortgage-backed securities, or bonds in the banks' investment portfolios.</P>
                <P>Libor exposure can exist in all product categories and lines of business, both on or off the balance sheet, and in asset management activities. Risk can also emanate from third-party relationships because Libor is often used in pricing models, financial models, and in other parts of banks' infrastructure, such as core processing.</P>
                <P>
                    The ubiquity of Libor, present in over $200 trillion notional contracts, makes moving off the rate incredibly complicated. Many existing contracts do not include sufficient provisions if Libor becomes unavailable (known as fallback provisions). Without adequate preparation, Libor cessation could cause market disruption and present risks to banks and their customers. In addition, fallback provision language does not sufficiently account for a permanent cessation of Libor. The Federal banking agencies published a statement communicating that banks should discontinue entering into contracts that use USD Libor as a reference rate as soon as practicable and in any event by the end of 2021 (with a few exceptions for orderly market support).
                    <SU>2</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">https://www.occ.gov/news-issuances/bulletins/2020/bulletin-2020-104.html#ft1.</E>
                    </P>
                </FTNT>
                <P>Given that the OCC expects banks to discontinue making Libor loans by the end of 2021, the prevalence of Libor, and the remaining work to be done within the timeframe described above, the OCC is making this self-assessment tool available to banks, due to the immediate need and the brief duration of use, to help banks prepare for Libor-related risk.</P>
                <P>
                    Banks may use the self-assessment to determine whether they have risk management processes in place to 
                    <PRTPAGE P="58725"/>
                    identify and mitigate their Libor transition risks. Not all sections or questions will apply to all banks. Applicable risks (
                    <E T="03">e.g.,</E>
                     operational, compliance, strategic, and reputation) can be identified when scoping and completing Libor cessation preparedness assessments.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Businesses or other for-profit.
                </P>
                <P>
                    <E T="03">Burden Estimates:</E>
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     1,096. 
                    <E T="03">Estimated Annual Burden:</E>
                     8,768 hours.
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Comments:</E>
                     Comments submitted in response to this notice will be summarized and included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on:
                </P>
                <P>(a) Whether the collections of information are necessary for the proper performance of the OCC's functions, including whether the information has practical utility;</P>
                <P>(b) The accuracy of the OCC's estimates of the burden of the information collections, 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 information collections on respondents, including through the use of automated collection techniques or other forms of information technology.</P>
                <P>(e) Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.</P>
                <SIG>
                    <NAME>Theodore J. Dowd,</NAME>
                    <TITLE>
                        Deputy Chief Counsel, 
                        <E T="03">Office of the Comptroller of the Currency.</E>
                    </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23056 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE TREASURY</AGENCY>
                <SUBJECT>Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple Alcohol and Tobacco Tax and Trade Bureau Information Collection Requests</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Departmental Offices, U.S. 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 must be received on or before November 22, 2021.</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 Molly Stasko by emailing 
                        <E T="03">PRA@treasury.gov,</E>
                         calling (202) 622-8922, or viewing the entire information collection request at 
                        <E T="03">www.reginfo.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Alcohol and Tobacco Tax and Trade Bureau (TTB)</HD>
                <P>
                    <E T="03">1. Title:</E>
                     Drawback on Distilled Spirits Exported.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1513-0042.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Under the IRC at 26 U.S.C. 5062, persons who export tax-paid distilled spirits may claim drawback of the alcohol excise tax paid on those spirits, as prescribed by regulation. The TTB regulations in 27 CFR part 28 require that claimants use TTB F 5110.30 to make such drawback claims. The form requests information regarding the claimant, the tax-paid spirits exported, and the amount of tax to be refunded. TTB uses the collected information to substantiate the claim for drawback.
                </P>
                <P>
                    <E T="03">Form:</E>
                     TTB F 5110.30.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Businesses or other for-profits.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     150.
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     On Occasion.
                </P>
                <P>
                    <E T="03">Estimated Total Number of Annual Responses:</E>
                     900.
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     2 hours.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     1,800 hours.
                </P>
                <P>
                    <E T="03">2. Title:</E>
                     Application and Permit to Ship Puerto Rican Spirits to the United States Without Payment of Tax.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1513-0043.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Description:</E>
                     The IRC at 26 U.S.C. 7652 imposes on Puerto Rican distilled spirits shipped to the United States for consumption or sale a tax equal to the internal revenue tax (excise tax) imposed in the United States on distilled spirits of domestic manufacture. However, the IRC at 26 U.S.C. 5232 provides that a person may withdraw distilled spirits imported or brought into the United States in bulk containers from Customs custody and transfer such spirits to the bonded premises of a domestic distilled spirits plant without payment of the internal revenue tax imposed on such spirits, as prescribed by regulation. The IRC at 26 U.S.C. 5314 also states that persons may withdraw spirits from the bonded premises of a distilled spirits plant in Puerto Rico pursuant to an authorization issued under the laws of Puerto Rico. Under those IRC authorities, the TTB regulations in 27 CFR part 26 require respondents to use form TTB F 5110.31 to apply for and receive approval to ship Puerto Rican distilled spirits to the United States without payment of Federal excise tax. The form identifies the specific spirits and amounts shipped and received, and the shipment's consignor in Puerto Rico and consignee in the United States. TTB uses the information collected to ensure appropriate application of the IRC tax provisions.
                </P>
                <P>
                    <E T="03">Form:</E>
                     TTB F 5110.31.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Businesses or other for-profits.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     10.
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     On Occasion.
                </P>
                <P>
                    <E T="03">Estimated Total Number of Annual Responses:</E>
                     500.
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     0.75 hour.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     375 hours.
                </P>
                <P>
                    <E T="03">3. Title:</E>
                     Distilled Spirits Production Records and Monthly Report of Production Operations.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1513-0047.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Description:</E>
                     In general, the IRC at 26 U.S.C. 5001 prescribes the excise tax rates for distilled spirits produced in or imported into the United States, while 26 U.S.C. 5207 requires distilled spirit plant (DSP) proprietors to maintain records of production, storage, denaturation, and processing activities and to render reports covering those operations, as prescribed by regulation. Under those IRC authorities, the TTB regulations in 27 CFR part 19 require DSP proprietors to keep records regarding the production materials used to produce spirits, the amount of spirits produced, the amount withdrawn from the production account, and the production of spirits byproducts, which proprietors must maintain for at least 3 years. Based on those records, the part 
                    <PRTPAGE P="58726"/>
                    19 regulations also require DSP proprietors to submit monthly reports of production operations using TTB F 5110.40. TTB uses the collected information to substantiate the proprietor's excise tax liability and bond coverage, if applicable.
                </P>
                <P>
                    <E T="03">Form:</E>
                     TTB F 5110.40.
                </P>
                <P>
                    <E T="03">Recordkeeping Number:</E>
                     TTB REC 5110/01.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Businesses or other for-profits.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     2,500.
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     Monthly.
                </P>
                <P>
                    <E T="03">Estimated Total Number of Annual Responses:</E>
                     30,000.
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     2 hours.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     60,000 hours.
                </P>
                <P>
                    <E T="03">4. Title:</E>
                     Wholesale Dealers Records of Receipt of Alcoholic Beverages, Disposition of Distilled Spirits, and Monthly Summary Reports.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1513-0065.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Description:</E>
                     The IRC at 26 U.S.C. 5121 requires wholesale alcohol beverage dealers to keep daily records of all distilled spirits received and disposed of, as well as daily records of all wine and beer received. That section also authorizes the Secretary of the Treasury to require such dealers to submit periodic summaries of their daily records for distilled spirits received and disposed of, and it authorizes the issuance of regulations regarding such records and reports. In addition, section 5123 of the IRC prescribes retention and inspection requirements for the required records and reports. Under those IRC authorities, the TTB regulations in 27 CFR part 31 require wholesale alcohol dealers to keep usual and customary business records, such as consignment, purchase, and sales invoices, to document their daily receipt and disposition of distilled spirits, as well as their daily receipt of wine and beer. The regulations also provide that TTB, at its discretion, may require a particular dealer to submit monthly summary reports regarding all distilled spirits received and disposed of on a daily basis. The regulations require dealers to keep the required records and copies of any required monthly summary reports at their place of business, available for TTB inspection, for at least 3 years.
                </P>
                <P>
                    <E T="03">Recordkeeping Number:</E>
                     TTB REC 5170/2.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Businesses or other for-profits.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     30,400 for recordkeeping; 50 for monthly summary reports.
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     Once for recordkeeping; Monthly for summary reports.
                </P>
                <P>
                    <E T="03">Estimated Total Number of Annual Responses:</E>
                     30,400 for recordkeeping; 600 for monthly summary reports.
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     None for recordkeeping; 2 hours for monthly summary reports.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     The keeping of usual and customary business records imposes no burden on respondents per the Office of Management and Budget regulations at 5 CFR 1320.3(b)(2). For monthly summary reports, the estimated total burden is 1,200 hours.
                </P>
                <P>
                    <E T="03">5. Title:</E>
                     Alcohol, Tobacco, and Firearms Related Documents for Tax Returns and Claims.
                </P>
                <P>
                    <E T="03">6. OMB Control Number:</E>
                     1513-0088.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Description:</E>
                     TTB is responsible for the collection of Federal excise taxes on distilled spirits, wine, beer, tobacco products, cigarette papers and tubes, and firearms and ammunition, and the collection of special occupational taxes related to tobacco products and cigarette papers and tubes. The IRC (26 U.S.C.) requires that such taxes be collected on the basis of a return, and it requires taxpayers to maintain records that support the information in the return. The IRC also allows for the filing of claims for the abatement or refund of taxes under certain circumstances, and it requires claimants to maintain records to support such claims. TTB uses the collected information to determine excise and special occupational tax liabilities, determine adequacy of bond coverage, and substantiate claims and other adjustments to tax liabilities.
                </P>
                <P>
                    <E T="03">Recordkeeping Number:</E>
                     TTB REC 5000/24.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Businesses or other for-profits; Not-for-profit institutions; and Individuals or households.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     67,000.
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Estimated Total Number of Annual Responses:</E>
                     536,000.
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     1 hour.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     536,000 hours.
                </P>
                <P>
                    <E T="03">7. Title:</E>
                     Federal Firearms and Ammunition Quarterly Excise Tax Return.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1513-0094.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Description:</E>
                     The IRC at 26 U.S.C. 4181 imposes a Federal excise tax on the sale of pistols, revolvers, other firearms, and shells and cartridges (ammunition) sold by manufacturers, producers, and Start Printed Page 31821importers of such articles. The IRC, at 26 U.S.C. 6001, 6011, and 6302, also authorizes the issuance of regulations regarding IRC-based taxes, returns, and records, including the mode and time for collecting taxes due. Under those IRC authorities, the TTB regulations in 27 CFR part 53 require respondents who have firearms and/or ammunition excise tax liabilities to submit a quarterly tax return using form TTB F 5300.26. TTB uses the information collected on this return to identify the taxpayer, the amount and type of taxes due, and the amount of payments made, and, as necessary, to support any tax determination or related additional actions, such as tax assessment or refund.
                </P>
                <P>
                    <E T="03">Form:</E>
                     TTB F 5300.26.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Businesses or other for-profits.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     715.
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Estimated Total Number of Annual Responses:</E>
                     2,860.
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     7 hours.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     20,020 hours.
                </P>
                <P>
                    <E T="03">8. Title:</E>
                     Reports of Removal, Transfer, or Sale of Processed Tobacco.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1513-0130.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Description:</E>
                     The IRC at 26 U.S.C. 5722 requires importers and manufacturers of tobacco products, processed tobacco, or cigarette papers and tubes to make reports as required by regulation. While processed tobacco is not subject to excise tax under the IRC, it may be illegally diverted to taxable use or supplied to others who illegally produce tobacco products. To detect diversion of processed tobacco, TTB has issued regulations in 27 CFR parts 40 and 41 requiring persons holding certain TTB-issued tobacco-related permits to report certain removals, transfers, or sales of processed tobacco. In general, respondents must report shipments for export or to domestic entities not holding such TTB-issued permits by the close of the next business day using form TTB F 5250.2. However, respondents may apply to TTB for approval to report removals made for export using a monthly summary report. TTB F 5250.2 and the monthly summary report require information identifying the TTB permit holder making the processed tobacco shipment, the type and quantity of processed tobacco 
                    <PRTPAGE P="58727"/>
                    shipped, the person(s) purchasing (or receiving) and delivering the processed tobacco, and the destination address of the shipment.
                </P>
                <P>
                    <E T="03">TTB Recordkeeping Number:</E>
                     TTB F 5250.2.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Businesses or other for-profits.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     26.
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     Daily, Monthly.
                </P>
                <P>
                    <E T="03">Estimated Total Number of Annual Responses:</E>
                     4,100.
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     0.5-2 hours.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     2,206 hours.
                </P>
                <P>
                    <E T="03">9. Title:</E>
                     Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1513-0132.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Description:</E>
                     TTB uses the surveys, focus groups, usability tests, and other information collections approved under this generic clearance to gather timely feedback from its customers and stakeholders regarding its programs and services. TTB analyzes the collected information to help improve its programs and service delivery to ensure that regulated persons and others have effective, efficient, and satisfactory experiences when interacting with the agency.
                </P>
                <P>
                    <E T="03">Form:</E>
                     None.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Businesses or other for-profits; and Individuals or Households.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     25,000.
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     Once.
                </P>
                <P>
                    <E T="03">Estimated Total Number of Annual Responses:</E>
                     25,000.
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     1 hour.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     25,000 hours.
                </P>
                <P>
                    <E T="03">10. Title:</E>
                     Specific and Continuing Export Bonds for Distilled Spirits or Wine.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1513-0135.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Description:</E>
                     The IRC at 26 U.S.C. 5175, 5214, and 5362 authorizes exporters (other than proprietors of distilled spirits plants or bonded wine premises) to withdraw distilled spirits and wine, without payment of tax, for export if the exporter provides a bond, as prescribed by regulation. To provide exporters with a degree of flexibility based on individual need, the TTB regulations in 27 CFR part 28 allow exporters to file either a specific bond using TTB F 5100.25 to cover a single shipment or a continuing bond using TTB F 5100.30 to cover export shipments made from time to time.
                </P>
                <P>
                    <E T="03">Form:</E>
                     TTB F 5100.25 and TTB F 5100.30.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Businesses or other for-profits.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     20.
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     Once.
                </P>
                <P>
                    <E T="03">Estimated Total Number of Annual Responses:</E>
                     20.
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     1 hour.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     20 hours.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                </P>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>Molly Stasko,</NAME>
                    <TITLE>Treasury PRA Clearance Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23115 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4810-31-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF VETERANS AFFAIRS</AGENCY>
                <SUBJECT>Voluntary Service National Advisory Committee, Notice of Meeting</SUBJECT>
                <P>The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Executive Committee of the VA Voluntary Service (VAVS) National Advisory Committee (NAC) will meet virtually on November 3-4, 2021. The meeting sessions will begin and end as follows:</P>
                <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s25,r25">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1" O="L">Meeting date(s):</CHED>
                        <CHED H="1" O="L">Meeting time(s):</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Wednesday, November 3, 2021</ENT>
                        <ENT>9:00 a.m. to 5:00 p.m. Eastern Standard Time (EST).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Thursday, November 4, 2021</ENT>
                        <ENT>9:00 a.m. to 12:00 p.m. EST.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>You may call into the meeting by dialing 1-872-701-0185 and enter Access Code 590 558 806#. The meeting sessions are open to the public.</P>
                <P>The Committee, comprised of 53 major Veteran, civic, and service organizations, advises the Secretary, through the Under Secretary for Health, on the coordination and promotion of volunteer activities and strategic partnerships within VA health care facilities, in the community, and on matters related to volunteerism and charitable giving. The Executive Committee consists of 20 representatives from the NAC member organizations.</P>
                <P>Agenda topics will include the NAC goals and objectives; review of minutes from the March 30, 2021, Executive Committee meeting; an update on VA Center for Development and Civic Engagement (CDCE) activities; Veterans Health Administration update; subcommittee reports; review of standard operating procedures; review of fiscal year 2021 organization data; panel discussion with CDCE Student Leadership Council representatives; 2022 NAC annual meeting plans; and any new business.</P>
                <P>
                    No time will be allocated at this meeting for receiving oral presentations from the public. However, the public may submit written statements for the Committee's review to Dr. Sabrina C. Clark, Designated Federal Officer, VA Center for Development and Civic Engagement (15CDCE), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, or email at 
                    <E T="03">Sabrina.Clark@VA.gov.</E>
                     Any member of the public wishing to attend the meeting or seeking additional information should contact Dr. Clark at 202-461-7300.
                </P>
                <SIG>
                    <DATED>Dated: October 19, 2021.</DATED>
                    <NAME>Jelessa M. Burney,</NAME>
                    <TITLE>Federal Advisory Committee Management Officer.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-23087 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF VETERANS AFFAIRS</AGENCY>
                <DEPDOC>[OMB Control No. 2900-NEW]</DEPDOC>
                <SUBJECT>Agency Information Collection Activity Under OMB Review: Application for Chapter 23 Burial Benefits</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Veterans Benefits Administration, Department of Veterans Affairs.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</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 
                        <PRTPAGE P="58728"/>
                        search function. Refer to “OMB Control No. 2900-NEW.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Maribel Aponte, Office of Enterprise and Integration, Data Governance Analytics (008), 1717 H Street NW, Washington, DC 20006, (202) 266-4688 or email 
                        <E T="03">maribel.aponte@va.gov.</E>
                         Please refer to “OMB Control No. 2900-NEW” in any correspondence.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Authority:</E>
                     38 U.S.C. 23; 38 U.S.C. 2302.
                </P>
                <P>
                    <E T="03">Title:</E>
                     Application for Chapter 23 Burial Benefits.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     2900-NEW.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Request for a NEW control number.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     A claimant's eligibility for needs-based pension programs are determined in part by countable family income and certain deductible expenses. Under the authority of 38 U.S.C. Chapter 23 “Burial Benefits,” including 38 U.S.C. 2302, VA uses the information provided on VA Form 21P-530EZ to evaluate respondents' eligibility for monetary burial benefits, including the burial allowance, plot or internment allowance, and transportation reimbursement. In these situations, VBA uses VA Form 21P-530EZ Application for Burial Benefits, to gather information that is necessary to determine eligibility for income-based benefits and the rate payable; without this information, determination of eligibility would not be possible. The program office submits 21P-530EZ (Under 38 U.S.C. Chapter 23) as a new form for electronic submissions (automation).
                </P>
                <P>
                    The program office requests removal of the 21P-530EZ (Under 38 U.S.C. Chapter 23), from the 2900-0003 series, as the form should have been submitted as a new form and the name has changed, requiring a separate control number. The 
                    <E T="04">Federal Register</E>
                     Notice with a 60-day comment period soliciting comments on this collection of information was published at 86 FR 156 on August 17, 2021, pages 46095.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individuals or Households.
                </P>
                <P>
                    <E T="03">Estimated Annual Burden:</E>
                     70,000 hours.
                </P>
                <P>
                    <E T="03">Estimated Average Burden per Respondent:</E>
                     30 minutes.
                </P>
                <P>
                    <E T="03">Frequency of Response: Once.</E>
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     140,000.
                </P>
                <SIG>
                    <P>By direction of the Secretary.</P>
                    <NAME>Maribel Aponte,</NAME>
                    <TITLE>VA PRA Clearance Officer, Office of Enterprise and Integration, Data Governance Analytics, Department of Veterans Affairs.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-23106 Filed 10-21-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8320-01-P</BILCOD>
        </NOTICE>
    </NOTICES>
    <VOL>86</VOL>
    <NO>202</NO>
    <DATE>Friday, October 22, 2021</DATE>
    <UNITNAME>Presidential Documents</UNITNAME>
    <PRESDOCS>
        <PRESDOCU>
            <EXECORD>
                <TITLE3>Title 3—</TITLE3>
                <PRES>
                    The President
                    <PRTPAGE P="58551"/>
                </PRES>
                <EXECORDR>Executive Order 14050 of October 19, 2021</EXECORDR>
                <HD SOURCE="HED">White House Initiative on Advancing Educational Equity, Excellence, and Economic Opportunity for Black Americans</HD>
                <FP>By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:</FP>
                <FP>
                    <E T="04">Section 1</E>
                    . 
                    <E T="03">Policy.</E>
                     Educational opportunity is a fundamental element of the American promise. The United States Supreme Court recognized in 1954 in 
                    <E T="03">Brown</E>
                     v. 
                    <E T="03">Board of Education</E>
                     that education “is a right which must be made available to all on equal terms.” In the decades since, our Nation has made progress in advancing equality and fairness in our schools, and the achievements, talents, and tenacity of Black students, educators, families, and scholars make our Nation's schools and communities stronger for all Americans. Black students are thriving in schools across the country, inside the classroom—as valedictorians and award-winning scientists—and outside of it, including in debate, athletics, student government, and national spelling bees, among many other areas.
                </FP>
                <FP>Over the course of America's history, Black Americans have helped to build, strengthen, and lead our Nation towards becoming a more perfect Union. Although for far too long, Black Americans were denied even the most basic access to education, the vital contributions of Black Americans in the fields of science, academia, business, and public service, among others, are a testament to the resilience of Black Americans and the steps our Nation has taken to expand access to education and opportunity.</FP>
                <FP>In spite of this progress, entrenched disparities continue to plague America's education system, holding far too many Black students back from achieving their full potential. Because of persistent racial and systemic injustices in our Nation, Black students remain more likely to attend high-poverty and racially segregated schools than White students. Black students are inequitably disciplined and suspended from school at disproportionately higher rates than White students for similar offenses. In addition, Black students too often face limited access to advanced and college-preparatory courses. Systemic racial disparities in education negatively impact learning outcomes for Black students and many face persistent gaps in reading and mathematics achievement. Studies show that school districts with high concentrations of Black students are much more likely to be underfunded than districts where a majority of students are White, and face much wider funding gaps, with an average deficit of more than $5,000 per student. Black students are still below the national average for educational attainment in high school, and that gap is even higher for college attainment rates, as 26 percent of Black Americans ages 25 and older have attained a bachelor's degree, while the national average is 36 percent. Black students also face unique challenges at the intersection of race and gender. Barriers to equity in education can compound for Black students who are also LGBTQ+ students, English-language learners, Dreamers, or students with disabilities.</FP>
                <FP>
                    These disparities result in long-standing college and postsecondary educational attainment gaps that affect life outcomes and access to opportunities. Although student populations are becoming increasingly diverse, Black teachers remain significantly underrepresented in our Nation's classrooms. Educational inequities have only widened throughout the COVID-19 pandemic, as Black students are more likely to experience remote learning challenges and greater learning loss as compared to their White peers. The persistent 
                    <PRTPAGE P="58552"/>
                    digital divide faced by some Black students has contributed to this disparity. It is a priority of my Administration to ensure an equitable recovery from COVID-19, and to provide all students with a successful return to the classroom.
                </FP>
                <FP>In the face of these historic and present-day inequities in our Nation's schools, Black students continue to persevere. Black students and scholars today are breaking the barriers confronted by generations who came before. Our Nation's schools and communities are irrefutably strengthened by the success, scholarship, and tenacity of Black students of all ages. But our Nation must go further to finally root out systemic barriers in our schools.</FP>
                <FP>Additionally, these barriers are present not just in the classroom, but also in the workplace. Black Americans face systemic obstacles to getting good jobs, gaps in wages and promotion, and higher incidences of reported workplace discrimination than White workers. Eliminating these inequities requires expanding access to work-based learning and leadership opportunities, including mentorships, sponsorships, internships, and registered apprenticeships that provide not only career guidance, but also the experience needed to navigate and excel in successful careers. In order for our Nation to equitably recover from the COVID-19 crisis, and to ensure that every Black person in America has a fair shot at the American dream, we must advance equity and excellence in public education and access to economic opportunities.</FP>
                <FP>It is the policy of my Administration to advance educational equity, excellence, and economic opportunity for Black Americans and communities from early childhood until their chosen career.</FP>
                <FP>
                    <E T="04">Sec. 2</E>
                    . 
                    <E T="03">White House Initiative on Advancing Educational Equity, Excellence, and Economic Opportunity for Black Americans.</E>
                     (a) To advance equity in our Nation's schools and to promote the economic opportunity that follows it, there is established in the Department of Education (Department) the White House Initiative on Advancing Educational Equity, Excellence, and Economic Opportunity for Black Americans (Initiative), of which the Secretary of Education (Secretary) shall serve as Chair. The Secretary shall designate an Executive Director for the Initiative (Executive Director).
                </FP>
                <P>(b) The Initiative shall advance educational equity and economic opportunity for Black students, families, and communities by focusing on the following policy goals:</P>
                <FP SOURCE="FP1">(i) increasing general understanding of systemic causes of educational challenges faced by many Black students, whether these students are in urban, suburban, rural, or migrant learning environments, and working across executive departments and agencies (agencies) to address these challenges;</FP>
                <FP SOURCE="FP1">(ii) increasing Black children's and families' access to and participation in high-quality early childhood programs and services that promote children's healthy development and learning, prepare them for success in school, and affirm their cultural identity;</FP>
                <FP SOURCE="FP1">(iii) addressing the inequitable treatment of Black children, such as eradicating discriminatory referrals to special education and excessive disciplinary actions;</FP>
                <FP SOURCE="FP1">(iv) supporting and improving data collection related to Black students and the implementation of evidence-based strategies to increase the participation and success of Black students in all levels of education and prepare them for careers and civic engagement;</FP>
                <FP SOURCE="FP1">
                    (v) ensuring that all Black students have access to excellent teachers, school leaders, and other professionals, including by supporting efforts to improve the recruitment, preparation, development, and retention of qualified, diverse teachers and school leaders and other professionals who understand students' lived experiences and can effectively meet their learning, social, and emotional needs;
                    <PRTPAGE P="58553"/>
                </FP>
                <FP SOURCE="FP1">(vi) enhancing student support services and fostering positive engagement among schools, families, community leaders, and community-based organizations to increase the high school graduation and post-secondary attendance rates and decrease the high school dropout rate for Black students;</FP>
                <FP SOURCE="FP1">(vii) promoting a positive school climate that supports equitable access to and participation in college-readiness, advanced placement courses, and internship opportunities, as well as innovative dropout prevention and recovery strategies that better engage Black youth in their learning, help them progress academically as needed, and provide those who have left the educational system with pathways to reentry;</FP>
                <FP SOURCE="FP1">(viii) eliminating discriminatory enrollment, housing, transportation, and other policies that lead to racial and socioeconomic segregation among and within schools;</FP>
                <FP SOURCE="FP1">(ix) ensuring equitable access to educational resources, professionals, and technology, including by addressing racial disparities in school funding and expenditures;</FP>
                <FP SOURCE="FP1">(x) breaking down barriers that impede the access of higher education institutions that serve Black students, such as Predominantly Black Institutions (PBIs) and Historically Black Colleges and Universities (HBCUs), to Federal funding, and strengthening the capacity of those institutions to participate in Federal programs and partnerships;</FP>
                <FP SOURCE="FP1">(xi) advancing racial equity and economic opportunity by connecting education to labor market needs through programs such as dual enrollment, career and technical education, registered apprenticeships, work-based learning, and career advancement, particularly in the fields of science, technology, engineering, and mathematics; and</FP>
                <FP SOURCE="FP1">(xii) ensuring that Black communities have access to resources for economic success, such as in the areas of financial education, small business development, entrepreneurship, arts, science, technology, engineering, and mathematics.</FP>
                <P>(c) In working to fulfill its mission and objectives, the Initiative shall, consistent with applicable law:</P>
                <FP SOURCE="FP1">(i) identify and promote evidence-based best practices that can provide Black students with a rigorous and well-rounded education in safe and healthy environments, as well as access to support services, that will improve their educational, professional, economic, and civic opportunities;</FP>
                <FP SOURCE="FP1">(ii) advance and coordinate efforts to ensure equitable opportunities for Black students in the re-opening process for schools across the country, and take steps to ensure that Black students, from early childhood to post-secondary education, can equitably recover from learning losses and other challenges faced during the COVID-19 pandemic;</FP>
                <FP SOURCE="FP1">(iii) encourage and develop partnerships with a national network of early childhood and early intervention providers, schools, institutions of higher education, and other public, private, philanthropic, and nonprofit stakeholders to improve access to educational equity and economic opportunities for Black Americans;</FP>
                <FP SOURCE="FP1">(iv) monitor and support the development, implementation, and coordination of Federal Government educational, workforce, research, and business development policies, programs, and technical assistance designed to improve outcomes for historically underserved communities, including Black Americans;</FP>
                <FP SOURCE="FP1">(v) work closely with the Executive Office of the President on key Administration priorities related to education, equity, and economic opportunity for Black Americans; and</FP>
                <FP SOURCE="FP1">
                    (vi) advise the Secretary on issues of importance to Black Americans and policies relating to educational equity, excellence, and economic opportunity for Black Americans.
                    <PRTPAGE P="58554"/>
                </FP>
                <P>(d) There is established a Federal Interagency Working Group, which shall be convened by the Executive Director and shall support the efforts of the Initiative. The Interagency Working Group shall collaborate regarding resources and opportunities available across the Federal Government to increase educational and economic opportunities for Black Americans.</P>
                <FP SOURCE="FP1">(i) The Interagency Working Group shall consist of senior officials (designated by the heads of their respective departments, agencies, and offices) from the following:</FP>
                <P SOURCE="P1">(A) the Department of State;</P>
                <P SOURCE="P1">(B) the Department of the Treasury;</P>
                <P SOURCE="P1">(C) the Department of Defense;</P>
                <P SOURCE="P1">(D) the Department of Justice;</P>
                <P SOURCE="P1">(E) the Department of the Interior;</P>
                <P SOURCE="P1">(F) the Department of Agriculture;</P>
                <P SOURCE="P1">(G) the Department of Commerce;</P>
                <P SOURCE="P1">(H) the Department of Labor;</P>
                <P SOURCE="P1">(I) the Department of Health and Human Services;</P>
                <P SOURCE="P1">(J) the Department of Housing and Urban Development;</P>
                <P SOURCE="P1">(K) the Department of Transportation;</P>
                <P SOURCE="P1">(L) the Department of Energy;</P>
                <P SOURCE="P1">(M) the Department of Education;</P>
                <P SOURCE="P1">(N) the Department of Veterans Affairs;</P>
                <P SOURCE="P1">(O) the Department of Homeland Security;</P>
                <P SOURCE="P1">(P) the White House Office of Management and Budget;</P>
                <P SOURCE="P1">(Q) the White House Office of Science and Technology Policy;</P>
                <P SOURCE="P1">(R) the Small Business Administration;</P>
                <P SOURCE="P1">(S) the White House Domestic Policy Council;</P>
                <P SOURCE="P1">(T) the White House Gender Policy Council;</P>
                <P SOURCE="P1">(U) the White House Office of Public Engagement;</P>
                <P SOURCE="P1">(V) the National Science Foundation;</P>
                <P SOURCE="P1">(W) the National Aeronautics and Space Administration;</P>
                <P SOURCE="P1">(X) the United States Agency for International Development; and</P>
                <P SOURCE="P1">(Y) such additional executive departments, agencies, and offices as the Secretary may designate.</P>
                <FP SOURCE="FP1">(ii) The Executive Director may establish subgroups of the Interagency Working Group to focus on different aspects of the educational system (such as PBIs and HBCUs, early childhood education, kindergarten through 12th grade education, children and adults with disabilities, teacher diversity, higher education, career and technical education, adult education, or correctional education and reengagement), economic opportunity (work-based learning, entrepreneurship, financial education, or mentorship), or educational challenges facing particular populations.</FP>
                <P>(e) Each agency designated to participate in the Interagency Working Group shall prepare a plan (Agency Plan) outlining measurable actions the agency will take to advance educational equity and economic opportunity for Black communities, including their plans to implement the policy goals and directives outlined in section 2(b) of this order and other relevant work. These plans shall be submitted to the Chair of the Initiative on a date established by the Chair.</P>
                <FP SOURCE="FP1">
                    (i) As appropriate, each Agency Plan shall include:
                    <PRTPAGE P="58555"/>
                </FP>
                <P SOURCE="P1">(A) a description of the applicable agency's efforts to ensure that Federal programs and initiatives administered by the Department and other agencies are meeting the educational needs of Black Americans, including efforts to incorporate best practices into appropriate discretionary programs where the agency sees fit and as permitted by law;</P>
                <P SOURCE="P1">(B) a description of how the applicable agency has and will decrease barriers to participation of Black Americans in Federal employment and student engagement opportunities;</P>
                <P SOURCE="P1">(C) a description of how the applicable agency can address challenges facing Black students and higher education institutions that serve Black students, such as PBIs and HBCUs, brought on by or exacerbated by the COVID-19 pandemic;</P>
                <P SOURCE="P1">(D) a description of how the agency's Office of Civil Rights, if applicable, can address discriminatory policies and practices that limit educational and economic opportunity for Black Americans;</P>
                <P SOURCE="P1">(E) any other information the applicable agency determines is relevant to promoting educational opportunities for Black Americans; and</P>
                <P SOURCE="P1">(F) information addressing any additional criteria established by the Chair or the Initiative.</P>
                <FP SOURCE="FP1">(ii) Each agency shall assess and report to the Chair on their progress in implementing the Agency Plan on a regular basis as established by the Chair.</FP>
                <FP SOURCE="FP1">(iii) The Initiative shall monitor and evaluate each agency's progress towards the goals established in its Agency Plan and shall coordinate with the agency to ensure that its Plan includes measurable and action-oriented goals.</FP>
                <P>(f) The Department shall provide funding and administrative support for the Initiative and the Interagency Working Group, to the extent permitted by law and within existing appropriations. To the extent permitted by law, including the Economy Act (31 U.S.C. 1535), other agencies and offices represented on the Interagency Working Group may detail personnel to the Initiative, to assist the Department in meeting the objectives of this order.</P>
                <P>(g) To advance shared priorities and policies that advance equity and economic opportunity for underserved communities, the Initiative shall collaborate and coordinate with other White House Initiatives related to equity and opportunity.</P>
                <P>(h) On an annual basis, the Chair shall report to the President on the Initiative's progress in carrying out its mission and function under this order.</P>
                <FP>
                    <E T="04">Sec. 3</E>
                    . 
                    <E T="03">Presidential Advisory Commission.</E>
                     (a) There is established in the Department a Presidential Advisory Commission on Advancing Educational Equity, Excellence, and Economic Opportunity for Black Americans (Commission).
                </FP>
                <P>(b) The Commission shall provide advice to the President through the Secretary on matters pertaining to educational equity and economic opportunity for the Black community, including:</P>
                <FP SOURCE="FP1">(i) what is needed for the development, implementation, and coordination of educational programs and initiatives at the Department and other agencies to improve educational opportunities and outcomes for Black Americans;</FP>
                <FP SOURCE="FP1">(ii) how to promote career pathways for in-demand jobs for Black students, including registered apprenticeships, internships, fellowships, mentorships, and work-based learning initiatives;</FP>
                <FP SOURCE="FP1">
                    (iii) how to increase public awareness of and generate solutions for the educational and training challenges and equity disparities that Black Americans face and the causes of these challenges; and
                    <PRTPAGE P="58556"/>
                </FP>
                <FP SOURCE="FP1">(iv) approaches to establish local and national partnerships with public, private, philanthropic, and nonprofit stakeholders to advance the mission and objectives of this order, consistent with applicable law.</FP>
                <P>(c) The Commission shall periodically report to the President, through the Secretary and after consulting with the Executive Director, on progress in addressing the mission of the Commission.</P>
                <P>(d) The Commission shall consist of not more than 21 members appointed by the President. The Commission may include individuals with relevant experience or subject matter expertise, as well as individuals who may serve as representatives from a variety of sectors, including education (early childhood education, elementary and secondary education, higher education, career and technical education, and adult education), labor organizations, research institutions, public and private philanthropic organizations, private sector, nonprofit, and community-based organizations at the national, State, Tribal, regional, or local levels. Commission members should be able to provide specific insight into the lived experiences of those served by the Initiative, including young adults, and have diversity across the Black diaspora and the geography of the country.</P>
                <FP SOURCE="FP1">(i) The President shall designate one member of the Commission to serve as its Chair. The Chair, in consultation with the Executive Director, shall convene regular meetings of the Commission, determine the Commission meeting agenda, and support the work of the Commission, consistent with this order.</FP>
                <FP SOURCE="FP1">(ii) The Commission shall meet on a regular basis, and at least twice a year.</FP>
                <P>(e) The Department shall provide funding and administrative support for the Commission, to the extent permitted by law and within existing appropriations. Members of the Commission shall serve without compensation but shall be allowed travel expenses, including per diem in lieu of subsistence, as authorized by law for persons serving intermittently in the Government service (5 U.S.C. 5701-5707). Insofar as the Federal Advisory Committee Act, as amended (5 U.S.C. App.), may apply to the administration of the Commission, any functions of the President under that Act, except that of reporting to the Congress, shall be performed by the Secretary, in accordance with guidelines issued by the Administrator of General Services.</P>
                <P>(f) The Commission shall terminate 2 years from the date of this order, unless extended by the President.</P>
                <FP>
                    <E T="04">Sec. 4</E>
                    . 
                    <E T="03">Administrative Provisions.</E>
                     (a) This order supersedes Executive Order 13621 of July 26, 2012 (White House Initiative on Educational Excellence for African Americans), which is hereby revoked. To the extent that there are other Executive Orders that may conflict with or overlap with the provisions in this order, the provisions in this order supersede those other Executive Orders on these subjects.
                </FP>
                <P>(b) The heads of agencies shall assist and provide information to the Initiative and the Commission established in this order, consistent with applicable law, as may be necessary to carry out the functions of the Initiative and the Commission.</P>
                <P>(c) Each agency shall bear its own expenses of participating in the Initiative established in this order.</P>
                <FP>
                    <E T="04">Sec. 5</E>
                    . 
                    <E T="03">General Provisions.</E>
                     (a) Nothing in this order shall be construed to impair or otherwise affect:
                </FP>
                <FP SOURCE="FP1">(i) the authority granted by law to an executive department or agency, or the head thereof; or</FP>
                <FP SOURCE="FP1">(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.</FP>
                <P>(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.</P>
                <PRTPAGE P="58557"/>
                <P>(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.</P>
                <GPH SPAN="1" DEEP="80" HTYPE="RIGHT">
                    <GID>BIDEN.EPS</GID>
                </GPH>
                <PSIG> </PSIG>
                <PLACE>THE WHITE HOUSE,</PLACE>
                <DATE>October 19, 2021.</DATE>
                <FRDOC>[FR Doc. 2021-23224 </FRDOC>
                <FILED>Filed 10-21-21; 8:45 am]</FILED>
                <BILCOD>Billing code 3395-F2-P</BILCOD>
            </EXECORD>
        </PRESDOCU>
    </PRESDOCS>
    <VOL>86</VOL>
    <NO>202</NO>
    <DATE>Friday, October 22, 2021</DATE>
    <UNITNAME>Proposed Rules</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="58729"/>
            <PARTNO>Part II</PARTNO>
            <AGENCY TYPE="P">Environmental Protection Agency</AGENCY>
            <CFR>40 CFR Part 761</CFR>
            <TITLE>Alternate PCB Extraction Methods and Amendments to PCB Cleanup and Disposal Regulations; Proposed Rule</TITLE>
        </PTITLE>
        <PRORULES>
            <PRORULE>
                <PREAMB>
                    <PRTPAGE P="58730"/>
                    <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                    <CFR>40 CFR Part 761</CFR>
                    <DEPDOC>[EPA-HQ-OLEM-2021-0556; FRL-7122-02-OLEM]</DEPDOC>
                    <RIN>RIN 2050-AH08</RIN>
                    <SUBJECT>Alternate PCB Extraction Methods and Amendments to PCB Cleanup and Disposal Regulations</SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Environmental Protection Agency (EPA).</P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Proposed rule.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>
                            The Environmental Protection Agency (EPA or the Agency) proposes to expand the available options for extraction and determinative methods used to characterize and verify the cleanup of polychlorinated biphenyls (PCBs) waste under the federal Toxic Substances Control Act (TSCA) regulations (also referred to as the PCB regulations). These proposed changes are expected to greatly reduce the amount of solvent used in PCB extraction processes, thereby conserving resources and reducing waste. In addition, the proposed changes are expected to result in quicker, more efficient, and less costly cleanups, due to greater flexibility in the cleanup and disposal of PCB waste, while still being equally protective of human health and the environment. EPA also proposes several other amendments to the PCB regulations, including the amendment of performance-based disposal option for PCB remediation waste; the removal of the provision allowing PCB bulk product waste to be disposed as roadbed material; the addition of more flexible provisions for cleanup and disposal of waste generated by spills that occur during emergency situations (
                            <E T="03">e.g.,</E>
                             hurricanes or floods); harmonizing the general disposal requirements for PCB remediation waste; and making other amendments to improve the implementation of the regulations, clarify ambiguity and correct technical errors.
                        </P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>Comments must be received on or before December 21, 2021. Under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before November 22, 2021.</P>
                    </EFFDATE>
                    <ADD>
                        <HD SOURCE="HED">ADDRESSES:</HD>
                        <P>Submit your comments, identified by Docket ID No. EPA-HQ-OLEM-2021-0556, by one of the following methods:</P>
                        <P>
                            • 
                            <E T="03">Federal eRulemaking Portal: 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 or other information whose disclosure is restricted by statute.
                        </P>
                        <P>
                            • 
                            <E T="03">Mail:</E>
                             U.S. Environmental Protection Agency, EPA Docket Center, OLEM Docket, Mail Code 28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460.
                        </P>
                        <P>
                            • 
                            <E T="03">Hand Delivery:</E>
                             To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at 
                            <E T="03">https://www.epa.gov/dockets/where-send-comments-epa-dockets.</E>
                        </P>
                        <P>
                            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/commenting-epa-dockets.</E>
                        </P>
                    </ADD>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>
                            For further information regarding specific aspects of this document, contact Jennifer McLeod, Program Implementation and Information Division, Office of Resource Conservation and Recovery, (703) 308-8459; email address: 
                            <E T="03">mcleod.jennifer@epa.gov,</E>
                             or Karen Swetland-Johnson, Program Implementation and Information Division, Office of Resource Conservation and Recovery, (703) 308-8421; email address: 
                            <E T="03">swetland-johnson.karen@epa.gov.</E>
                        </P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <HD SOURCE="HD1">I. General Information</HD>
                    <HD SOURCE="HD2">A. Does this action apply to me?</HD>
                    <P>This proposed rule potentially affects persons that manufacture, process, distribute in commerce, use, or dispose of PCBs. The following list of North American Industrial 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>
                        • 
                        <E T="03">Utilities:</E>
                         Electric power and light companies, natural gas companies (NAICS code 22);
                    </P>
                    <P>
                        • 
                        <E T="03">Manufacturers:</E>
                         Chemical manufacturers, electroindustry manufacturers, end-users of electricity, general contractors (NAICS codes 31-33);
                    </P>
                    <P>
                        • 
                        <E T="03">Transportation and Warehousing:</E>
                         Various modes of transportation including air, rail, water, ground, and pipeline (NAICS code 48-49);
                    </P>
                    <P>
                        • 
                        <E T="03">Real Estate:</E>
                         People who rent, lease, or sell commercial property (NAICS code 53);
                    </P>
                    <P>
                        • 
                        <E T="03">Professional, Scientific and Technical Services:</E>
                         Testing laboratories, environmental consulting (NAICS code 54);
                    </P>
                    <P>
                        • 
                        <E T="03">Public Administration:</E>
                         Federal, state, and local agencies (NAICS code 92);
                    </P>
                    <P>
                        • 
                        <E T="03">Waste Management and Remediation Services</E>
                        : PCB waste handlers (
                        <E T="03">e.g.,</E>
                         storage facilities, landfills, incinerators), waste treatment and disposal, remediation services, material recovery facilities, waste transporters (NAICS code 562);
                    </P>
                    <P>
                        • 
                        <E T="03">Repair and Maintenance:</E>
                         Repair and maintenance of appliances, machinery and equipment (NAICS code 811);
                    </P>
                    <P>
                        To determine whether your entity is affected by this action, you should carefully examine the proposed changes to the regulatory text. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                        .
                    </P>
                    <HD SOURCE="HD2">B. What action is the Agency taking?</HD>
                    <P>
                        EPA proposes to expand the list of extraction and determinative methods in the PCB regulations (40 CFR part 761); amend the performance-based cleanup option for PCB remediation waste under § 761.61(b); remove the provision allowing PCB bulk product waste to be disposed as roadbed material; add more flexible provisions for cleaning up spills that occur during emergency situations, such as during a hurricane or flood; harmonize the general disposal requirements for PCB remediation waste; and make several other amendments to improve the implementation of the regulations, clarify ambiguity, and correct technical errors and outdated information. In addition to the proposed regulatory changes to 40 CFR part 761 included in this notice, EPA has also included a redline mark-up of the proposed changes as a supporting document in the docket, titled 
                        <E T="03">Redline Version of Proposed Revisions to 40 CFR part 761 (PCB Regulations; NPRM).</E>
                         This transparency will assist the public in visualizing what EPA is proposing to change in the regulatory text at 40 CFR part 761, by showing what is proposed to be added to and removed from the current version of the regulatory text.
                    </P>
                    <HD SOURCE="HD2">C. What is the Agency's authority for taking this action?</HD>
                    <P>
                        The authority to propose this rule is found in section 6(e)(1) of TSCA. Specifically, section 6(e)(1)(A) gives 
                        <PRTPAGE P="58731"/>
                        EPA the authority to promulgate rules regarding the disposal of PCBs (15 U.S.C. 2605(e)(1)(A)).
                    </P>
                    <HD SOURCE="HD2">D. What are the overall economic impacts of this action?</HD>
                    <P>EPA estimated the costs and benefits of the proposed rule in an Economic Assessment, which is available in the docket for this action. Overall, EPA estimates that the proposed rule would result in quantifiable annual cost savings of approximately $13.5 million to $15.2 million (annualized at a discount rate of seven percent).</P>
                    <HD SOURCE="HD2">E. What is the scope of this proposed rule?</HD>
                    <P>This proposed rule addresses several key issues related to implementing the PCB Cleanup and Disposal Program under TSCA, including:</P>
                    <HD SOURCE="HD3">Expand Available Extraction Methods</HD>
                    <P>EPA proposes to add the following extraction methods from SW-846, Test Methods for Evaluating Solid Waste, to the PCB regulations in 40 CFR part 761 for use on solid matrices: Method 3541 (Automated Soxhlet Extraction), Method 3545A (Pressurized Fluid Extraction), and Method 3546 (Microwave Extraction). EPA is also proposing to add the following aqueous extraction methods to the PCB regulations: Method 3510C (Separatory Funnel Liquid-Liquid Extraction), Method 3520C (Continuous Liquid-Liquid Extraction), and Method 3535A (Solid-Phase Extraction). The Agency is proposing to incorporate by reference Methods 3541, 3545A, 3546, 3510C, 3520C, and 3535A into § 761.19.</P>
                    <HD SOURCE="HD3">Remove Ultrasonic Extraction</HD>
                    <P>EPA proposes to remove SW-846 Method 3550B (Ultrasonic extraction) from the PCB regulations in 40 CFR part 761.</P>
                    <HD SOURCE="HD3">Add Determinative Methods</HD>
                    <P>EPA proposes to add three determinative methods to the PCB regulations: SW-846 Method 8082A (Polychlorinated Biphenyls (PCBs) By Gas Chromatography); 8275A (Semivolatile Organic Compounds (PAHs And PCBs) In Soils/Sludges And Solid Wastes Using Thermal Extraction/Gas Chromatography/Mass Spectrometry (TE/GC/MS)); and Clean Water Act (CWA) Method 1668C (Chlorinated Biphenyl Congeners in Water, Soil, Sediment, Biosolids, and Tissue by HRGC/HRMS).</P>
                    <HD SOURCE="HD3">Amend the Performance-Based Disposal Option Under § 761.61(b)</HD>
                    <P>EPA proposes to amend the performance-based disposal option for PCB remediation waste under § 761.61(b) to include provisions for performance-based cleanup such as applicability, cleanup levels, verification sampling, recordkeeping and notification requirements. EPA is also proposing to add RCRA Subtitle C permitted landfills to the list of allowable performance-based disposal options for non-liquid PCB remediation waste.</P>
                    <HD SOURCE="HD3">Remove Regulatory Provision Allowing Disposal of PCB Bulk Product Waste as Roadbed</HD>
                    <P>EPA proposes to remove the option in § 761.62(d)(2), which allows for disposal of PCB bulk product waste under asphalt as part of a roadbed.</P>
                    <HD SOURCE="HD3">Add Flexible Provisions for Emergency Situations</HD>
                    <P>EPA proposes to add two provisions to the existing PCB Spill Cleanup Policy in 40 CFR part 761, subpart G, that would allow for more flexible requirements for cleanup of spills caused by and managed in emergency situations, such as hurricane or floods. Additionally, EPA is proposing to add provisions to allow individuals to request a waiver from specific requirements of §§ 761.60, 761.61, 761.62, and 761.65, when necessitated by an emergency situation.</P>
                    <HD SOURCE="HD3">Harmonize General Disposal Requirements for PCB Remediation Waste</HD>
                    <P>EPA proposes to amend § 761.50(b)(3)(ii) to remove a phrase that was added erroneously in 1998, which could imply that waste with &lt;50 ppm PCBs that met the definition of PCB remediation waste in § 761.3 was not regulated for disposal.</P>
                    <HD SOURCE="HD3">Make Changes To Improve Regulatory Implementation</HD>
                    <P>EPA proposes several supplemental amendments to improve implementation of existing requirements, clarify regulatory ambiguity and correct technical errors in the PCB regulations.</P>
                    <P>
                        More information on each of the above proposed changes can be found in 
                        <E T="03">Section III, Detailed Discussion of the Proposed Rule.</E>
                    </P>
                    <HD SOURCE="HD1">II. Background</HD>
                    <HD SOURCE="HD2">A. General Background on Polychlorinated Biphenyls (PCBs) and This Rulemaking</HD>
                    <HD SOURCE="HD3">What are PCBs?</HD>
                    <P>
                        PCBs are a group of man-made organic chemicals known as chlorinated hydrocarbons, which consist of carbon, hydrogen and chlorine atoms. PCBs were manufactured in the United States from 1929 until fabrication was banned in 1979. (As allowed by TSCA, the PCB regulations provide for excluded manufacturing processes, as defined in 40 CFR 761.3, which include inadvertent generation.) The number of chlorine atoms and their location in a PCB molecule determine many of its physical and chemical properties. PCBs have no known taste or smell, and range in consistency from thin, light-colored liquids to yellow or black waxy solids. Due to their non-flammability, chemical stability, high boiling point and electrical insulating properties, PCBs were previously used in hundreds of industrial and commercial applications including: Electrical, heat transfer and hydraulic equipment; plasticizers in paints, plastics and rubber products; pigments, dyes and carbonless copy paper; and other industrial applications. The PCBs used in these products were chemical mixtures made up of a variety of individual chlorinated biphenyl components known as congeners. Most commercial PCB mixtures are known in the United States by their industrial trade names, the most common being Aroclor. Please visit: 
                        <E T="03">https://www.epa.gov/pcbs/learn-about-polychlorinated-biphenyls-pcbs</E>
                         for more information.
                    </P>
                    <HD SOURCE="HD3">
                        PCB Exposures and Health Effects 
                        <E T="51">1 2 3</E>
                        <FTREF/>
                    </HD>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             Thomas, Xue, Williams, Jones, and Whitaker. “Polychlorinated Biphenyls (PCBs) in School Buildings: Sources, Environmental Levels, and Exposures”; Office of Research and Development, National Exposure Laboratory; Washington, DC. September 2012.
                        </P>
                        <P>
                            <SU>2</SU>
                             ATSDR. Toxicological Profile for Polychlorinated Biphenyls (PCBs); U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry. November 2000.
                        </P>
                        <P>
                            <SU>3</SU>
                             ATSDR. Addendum to the Toxicological Profile for Polychlorinated Biphenyls; U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry. April 2011.
                        </P>
                    </FTNT>
                    <P>
                        PCBs are persistent in the environment and can cause both acute and chronic health effects. Short-term exposure to high concentrations of PCBs can lead to skin conditions such as acne and rashes and may be associated with decreased liver function, neurological effects and gastrointestinal effects. 
                        <PRTPAGE P="58732"/>
                        These high levels of exposure are generally rare in the general population. Chronic exposure to lower concentrations of PCBs may also cause health effects, as PCBs can accumulate in people over time. In animal studies, PCBs have been shown to cause effects on the immune, reproductive, nervous, hepatic and endocrine systems. PCBs have also been shown to cause cancer in animals. Some studies in humans provide supportive evidence for some of these health effects. Studies also show that PCBs in pregnant women can affect their children's birth weight, short-term memory and learning. Also, because of potential neurotoxic and endocrine effects, there is concern regarding children's exposures to PCBs.
                    </P>
                    <P>PCBs are highly persistent in the environment. As such, they are still present in soils and sediments at many locations and may be found at low levels in ambient air and water, even decades after banning them. PCBs can be released into the environment from hazardous waste sites, illegal or improper disposal of industrial wastes and consumer products, leaks from old electrical transformers and capacitors containing PCBs and burning of some wastes in incinerators, among other sources. PCBs bioaccumulate and may be present in foods that people consume, such as fish, meat and dairy products. Dietary consumption of contaminated foods is believed to be an important route of background exposure.</P>
                    <HD SOURCE="HD3">Laws and Regulations</HD>
                    <P>This proposed rule is issued pursuant to section 6(e) of the Toxic Substances Control Act, 15 U.S.C. 2605(e). Section 6(e)(1)(A) gives EPA the authority to promulgate rules regarding the disposal of PCBs (15 U.S.C. 2605(e)(1)(A)). TSCA section 6(e)(2) and (e)(3) generally prohibit the manufacture, processing, distribution in commerce and use (other than totally enclosed use) of PCBs (15 U.S.C. 2605(e)(2) and (e)(3)). TSCA section 6(e)(2)(B) gives EPA the authority to authorize the use of PCBs in other than a totally enclosed manner based on a finding of no unreasonable risk of injury to health or the environment (15 U.S.C. 2605(e)(2)(B)). TSCA section 6(e)(3)(B) provides that any person may petition EPA for an exemption from the prohibition on the manufacture, processing, and distribution in commerce of PCBs (15 U.S.C. 2605(e)(3)(B)). EPA may grant an exemption based on findings that an unreasonable risk of injury to health or the environment will not result, and that the petitioner has made good faith efforts to develop a substitute for PCBs.</P>
                    <P>
                        The implementing PCB regulations can be found in title 40 of the Code of Federal Regulations (CFR) in part 761. For useful interpretations of the regulations as well as answers to frequently asked questions please visit 
                        <E T="03">https://www.epa.gov/pcbs/policy-and-guidance-polychlorinated-biphenyl-pcbs.</E>
                    </P>
                    <HD SOURCE="HD3">Rationale for Updating Portions of the PCB Regulations</HD>
                    <P>Several developments have occurred in recent years to warrant an update to portions of the PCB regulations, including: The emergence of new science, advancement of analytical methods and technology, new information, and repeated requests from the regulated community to address their concerns and areas of confusion.</P>
                    <P>EPA is thus proposing several revisions to the PCB regulations to better reflect current science and other available new information. This rulemaking is expected to ease regulatory burden and costs on the regulated community and on EPA by providing greater flexibility while maintaining environmental protectiveness in the allowable extraction and determinative methods used to characterize and verify the cleanup of PCB waste. This rulemaking is also expected to ease regulatory burden by improving the implementation of the regulations, clarifying ambiguity and correcting technical errors.</P>
                    <HD SOURCE="HD2">B. Assumptions and Terminology Used in Discussion of Various Methods</HD>
                    <HD SOURCE="HD3">Sources of the Methods</HD>
                    <P>
                        There are two important sources of EPA methods related to this rulemaking. The first source is SW-846, also known as 
                        <E T="03">The Test Methods for Evaluating Solid Waste: Physical/Chemical Methods Compendium,</E>
                         which is EPA's collection of methods for use in complying with the Resource Conservation and Recovery Act (RCRA). SW-846 is organized into chapters providing guidance on how to use the methods and groups of methods, called “series,” which are organized by topic. The methods change over time as updates are published to keep up with evolving analytical and measurement needs.
                        <SU>4</SU>
                        <FTREF/>
                         The second source is the Clean Water Act (CWA) Methods, which are EPA published laboratory methods, or test procedures that are used by industries and municipalities, to analyze the chemical, physical and biological components of wastewater and other environmental samples.
                        <SU>5</SU>
                        <FTREF/>
                         Methods for both SW-846 and CWA go through an extensive review and validation process before they are made available.
                    </P>
                    <FTNT>
                        <P>
                            <SU>4</SU>
                             
                            <E T="03">https://www.epa.gov/hw-sw846</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>5</SU>
                             
                            <E T="03">https://www.epa.gov/cwa-methods</E>
                            .
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Terminology of the Methods</HD>
                    <P>EPA would like to avoid confusion with the variety of methods discussed, the source of each method, and the numbering of the methods. EPA will use streamlined nomenclature in this preamble to improve its readability. For example, rather than stating, “SW-846, Test Methods for Evaluating Solid Waste, EPA Method 3540C (Soxhlet Extraction),” EPA will only state “Method 3540C”. This terminology applies to all subsequent sections in this preamble. See Table 1 for a comprehensive list of all methods referenced in this document.</P>
                    <GPOTABLE COLS="6" OPTS="L2,nj,i1" CDEF="xs40,xs70,12,r25,r75,r50">
                        <TTITLE>Table 1—Table of Methods Discussed in This Rulemaking</TTITLE>
                        <BOXHD>
                            <CHED H="1">Source</CHED>
                            <CHED H="1">Method ID</CHED>
                            <CHED H="1">Publication year</CHED>
                            <CHED H="1">Method type</CHED>
                            <CHED H="1">Method name</CHED>
                            <CHED H="1">Proposed change</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">SW-846</ENT>
                            <ENT>Method 3510C</ENT>
                            <ENT>1996</ENT>
                            <ENT>Extraction</ENT>
                            <ENT>Separatory Funnel Liquid-Liquid Extraction</ENT>
                            <ENT>Propose to Add.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">SW-846</ENT>
                            <ENT>Method 3520C</ENT>
                            <ENT>1996</ENT>
                            <ENT>Extraction</ENT>
                            <ENT>Continuous Liquid-Liquid Extraction</ENT>
                            <ENT>Propose to Add.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">SW-846</ENT>
                            <ENT>Method 3535A</ENT>
                            <ENT>2007</ENT>
                            <ENT>Extraction</ENT>
                            <ENT>Solid-Phase Extraction (SPE)</ENT>
                            <ENT>Propose to Add.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">SW-846</ENT>
                            <ENT>Method 3500B</ENT>
                            <ENT>2007</ENT>
                            <ENT>Extraction</ENT>
                            <ENT>Organic Extraction and Sample Preparation</ENT>
                            <ENT>Propose to Remove Reference to Method.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">SW-846</ENT>
                            <ENT>Method 3540C</ENT>
                            <ENT>1996</ENT>
                            <ENT>Extraction</ENT>
                            <ENT>Soxhlet Extraction</ENT>
                            <ENT>Remains in regulations.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">SW-846</ENT>
                            <ENT>Method 3541</ENT>
                            <ENT>1994</ENT>
                            <ENT>Extraction</ENT>
                            <ENT>Automated Soxhlet Extraction</ENT>
                            <ENT>Propose to Add.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">SW-846</ENT>
                            <ENT>Method 3545A</ENT>
                            <ENT>2007</ENT>
                            <ENT>Extraction</ENT>
                            <ENT>Pressurized Fluid Extraction</ENT>
                            <ENT>Propose to Add.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">SW-846</ENT>
                            <ENT>Method 3546</ENT>
                            <ENT>2007</ENT>
                            <ENT>Extraction</ENT>
                            <ENT>Microwave Extraction</ENT>
                            <ENT>Propose to Add.</ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="58733"/>
                            <ENT I="01">SW-846</ENT>
                            <ENT>Method 3550B</ENT>
                            <ENT>1996</ENT>
                            <ENT>Extraction</ENT>
                            <ENT>Ultrasonic Extraction</ENT>
                            <ENT>Propose to Remove.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">SW-846</ENT>
                            <ENT>Method 8082</ENT>
                            <ENT>1996</ENT>
                            <ENT>Determinative</ENT>
                            <ENT>Polychlorinated Biphenyls (PCBs) by Gas Chromatography</ENT>
                            <ENT>Remains in regulations.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">SW-846</ENT>
                            <ENT>Method 8082A</ENT>
                            <ENT>2007</ENT>
                            <ENT>Determinative</ENT>
                            <ENT>Polychlorinated Biphenyls (PCBs) by Gas Chromatography</ENT>
                            <ENT>Propose to Add.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">SW-846</ENT>
                            <ENT>Method 8275A</ENT>
                            <ENT>1996</ENT>
                            <ENT>Extraction and Determinative</ENT>
                            <ENT>Semivolatile Organic Compounds in Soil/Sludges and Solid Wastes Using Thermal Extraction/Gas Chromatography/Mass Spectrometry (TE/GC/MS)</ENT>
                            <ENT>Propose to Add.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CWA</ENT>
                            <ENT>Method 1668C</ENT>
                            <ENT>2010</ENT>
                            <ENT>Extraction and Determinative</ENT>
                            <ENT>Chlorinated Biphenyl Congeners in Water, Soil, Sediment, Biosolids, and Tissue by HRGC/HRMS</ENT>
                            <ENT>Propose to Add.</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD1">III. Detailed Discussion of the Proposed Rule</HD>
                    <HD SOURCE="HD2">A. Expand Available Extraction Methods for PCBs</HD>
                    <HD SOURCE="HD3">Background on Extraction Methods for PCBs</HD>
                    <P>
                        Currently, the only extraction methods explicitly allowed in the PCB regulations for solid matrices are Method 3540C (Soxhlet Extraction), which is commonly referred to as `Manual Soxhlet Extraction,' and Method 3550B (Ultrasonic Extraction). The regulated community has long expressed interest in the availability of extraction methods at cleanup sites beyond those currently allowed under the PCB regulations.
                        <SU>6</SU>
                        <FTREF/>
                         The data on Method 3550B indicate that it has the potential to produce unreliable and inconsistent results. For more information on this issue, see 
                        <E T="03">Section III.B. Remove Ultrasonic Extraction (Method 3550B) from the PCB Regulations.</E>
                         Manual Soxhlet Extraction was invented in the late 1800s and the original Method 3540C was created in 1996. It is a long-standing, effective method for PCBs; however, over time it has slowly been replaced by newer methods in both EPA and commercial laboratories.
                        <SU>7</SU>
                        <FTREF/>
                         This transition has caused problems with the availability of Manual Soxhlet Extraction in EPA and commercial laboratories, which could potentially cause delays in getting samples extracted and analyzed in a timely matter. In addition, Manual Soxhlet Extraction takes 16-24 hours (whereas other methods may take only 2-4 hours, or less) to complete the extraction of a limited number of samples, which could result in further delays.
                    </P>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             Allison D. Foley “Consolidated Petition on Behalf of USWAG Members to Use Automated Soxhlet Extraction (Method 3541) in Connection with June 10, 2014 Risk-Based Approvals to Dispose of Polychlorinated Biphenyl (PCB) Remediation Waste”; March 2015.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>7</SU>
                             M.D. Luque de Castro, L.E. García-Ayuso. “Soxhlet extraction of solid materials: An outdated technique with a promising innovative future.” Department of Analytical Chemistry, Faculty of Sciences, University of Cordoba. Cordoba, Spain. March 1998.
                        </P>
                    </FTNT>
                    <P>Although the PCB regulations explicitly allow these extraction methods, neither of these methods are applicable to PCB extraction of aqueous samples. Method 8082 is currently the only determinative method listed in the PCB regulations for extraction from aqueous matrices and states that “[a]queous samples may be extracted at neutral pH with methylene chloride using either Method 3510 (separatory funnel), Method 3520 (continuous liquid-liquid extraction), Method 3535A (solid-phase extraction) or other appropriate technique or solvents.”</P>
                    <P>
                        EPA proposes to add the following extraction methods to the 40 CFR part 761 regulations: Method 3541 
                        <SU>8</SU>
                        <FTREF/>
                         (Automated Soxhlet Extraction), Method 3545A 
                        <SU>9</SU>
                        <FTREF/>
                         (Pressurized Fluid Extraction), and Method 3546 
                        <SU>10</SU>
                        <FTREF/>
                         (Microwave Extraction) for extraction of PCBs from solid matrices; and Method 3510C 
                        <SU>11</SU>
                        <FTREF/>
                         (Separatory Funnel Liquid-Liquid Extraction), Method 3520C 
                        <SU>12</SU>
                        <FTREF/>
                         (Continuous Liquid-Liquid Extraction), and Method 3535A 
                        <SU>13</SU>
                        <FTREF/>
                         (Solid-Phase Extraction) for extraction of PCBs from aqueous matrices. EPA is also proposing to add determinative methods to the PCB regulations at 40 CFR part 761 (see 
                        <E T="03">Section III.C. Proposed Updates to Determinative Methods for PCBs</E>
                        ). Although not explicitly allowable at this time for determining PCB concentrations for purposes of the PCB disposal and cleanup regulations, these methods are already widely used in both EPA and commercial laboratories for PCB extraction under other cleanup programs, such as cleanups under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and state-led cleanups. These methods are as accurate as and offer several significant benefits over Manual Soxhlet Extraction, including quicker sample processing time (a few hours or less compared to 16-24 hours), less need for physical space for equipment, reduced solvent use and energy savings. Because of these advantages, most EPA and commercial labs already use these Methods for extracting PCBs from samples. EPA finds, based on reasonably available information, that expanding the options for alternative extraction methods in the PCB regulations would help the regulated community investigate, clean up and dispose of PCB waste more quickly, efficiently, and economically, with results that are as accurate as or more accurate than the results using 
                        <PRTPAGE P="58734"/>
                        3540C. Furthermore, the use of less solvent during the extraction procedure would advance Agency priorities on the use of greener technologies in cleanup and disposal actions.
                        <SU>14</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>8</SU>
                             U.S. EPA, Method 3541 Automated Soxhlet Extraction. Office of Land and Emergency Management, Office of Resource Conservation and Recovery, Materials Recovery and Waste Management Division (5303P). Washington, DC. EPA-820-R-10-004. September 1994.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>9</SU>
                             U.S. EPA, Method 3545A Pressurized Fluid Extraction. Office of Land and Emergency Management, Office of Resource Conservation and Recovery, Materials Recovery and Waste Management Division (5303P). Washington, DC. EPA-820-R-10-004. January 1998.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>10</SU>
                             U.S. EPA, Method 3546 Microwave Extraction. Office of Land and Emergency Management, Office of Resource Conservation and Recovery, Materials Recovery and Waste Management Division (5303P). Washington, DC. EPA-820-R-10-004. February 2007.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             U.S. EPA, Method 3510C Separatory Funnel Liquid-Liquid Extraction. Office of Land and Emergency Management, Office of Resource Conservation and Recovery, Materials Recovery and Waste Management Division (5303P). Washington, DC. December 1996.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>12</SU>
                             U.S. EPA, Method 3520C Continuous Liquid-Liquid Extraction. Office of Land and Emergency Management, Office of Resource Conservation and Recovery, Materials Recovery and Waste Management Division (5303P). Washington, DC. December 1996.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>13</SU>
                             U.S. EPA, Method 3535A Solid-Phase Extraction. Office of Land and Emergency Management, Office of Resource Conservation and Recovery, Materials Recovery and Waste Management Division (5303P). Washington, DC. February 2007.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>14</SU>
                             
                            <E T="03">https://www.epa.gov/sites/production/files/2015-10/documents/oswer_greencleanup_principles.pdf.</E>
                        </P>
                    </FTNT>
                    <P>Therefore, EPA proposes to add several additional extraction methods to the PCB Regulations, which will allow for more flexibility in the allowable extraction methods. See the following section for more information on EPA's proposed extraction methods.</P>
                    <HD SOURCE="HD3">Technical Summary of Relevant Extraction Methods</HD>
                    <P>
                        <E T="03">EPA Method 3540C:</E>
                         Soxhlet Extraction (aka Manual Soxhlet Extraction) is currently the primary extraction method used under the PCB regulations. When performing a Manual Soxhlet Extraction, the solid sample is mixed with anhydrous sodium sulfate, placed in an extraction thimble or between two plugs of glass wool, and extracted using an appropriate solvent in a Soxhlet extractor. The extract is then dried, concentrated (if necessary) and exchanged into a solvent compatible with the cleanup or determinative step being employed (if necessary). For certain types of matrices, such as non-liquid manufactured materials, this method may be the most suitable option to ensure effective extraction of PCBs for quantitative analysis.
                    </P>
                    <P>
                        <E T="03">EPA Method 3550B:</E>
                         Ultrasonic Extraction (UE) is a method currently permissible in the PCB regulations that can be used to extract PCBs from solids, such as soils, sludges and wastes. There are two procedures in the method depending on the expected concentration of organic compounds. Under the low concentration procedure, the sample is mixed with anhydrous sodium sulfate to form a free-flowing powder. The mixture is extracted with solvent three times, using an ultrasonic extractor, which uses pulsing energy to extract the targeted analyte. The extract is separated from the sample by vacuum filtration or centrifugation. The extract is then ready for final concentration, cleanup and/or analysis. Under the medium/high concentration procedure, the sample is mixed with anhydrous sodium sulfate to form a free-flowing powder. The sample is extracted with solvent once, using ultrasonic extraction. A portion of the extract is then collected for cleanup and/or analysis. Because of the limited contact time between the solvent and the sample, Ultrasonic Extraction may not be as rigorous as other extraction methods for soils/solids. Therefore, it is critical that the method (including the manufacturer's instructions) be followed exactly, to achieve the maximum extraction efficiency.
                    </P>
                    <P>
                        <E T="03">EPA is proposing to add EPA Method 3546:</E>
                         Microwave Extraction to the PCB regulations. This method is known for its relatively brief extraction time and low equipment costs. In a microwave extraction, a sample is prepared for extraction by grinding it to a powder and then loading it into the extraction vessel. The appropriate solvent system is added to the vessel, which is then sealed. The extraction vessel containing the sample and solvent system is then heated to the extraction temperature and is extracted for the amount of time recommended by the instrument manufacturer. After the mixture cools, the vessel is opened and the contents are filtered. The solid material is then rinsed multiple times, and the various solvent fractions are combined. Finally, the extract may be concentrated, if necessary, and, as needed, exchanged into a solvent compatible with the cleanup or determinative procedure to be employed.
                    </P>
                    <P>
                        <E T="03">EPA is also proposing to add EPA Method 3545A:</E>
                         Pressurized Fluid Extraction (PFE) to the PCB Regulations. When performing a pressurized fluid extraction, a sample is prepared for extraction either by air drying the sample, or by mixing the sample with anhydrous sodium sulfate or pelletized diatomaceous earth. The sample is then ground and loaded into an extraction cell. The extraction cell containing the ground sample is then heated to the extraction temperature, pressurized with the appropriate solvent system, and extracted for the period of time recommended by the instrument manufacturer. The solvent is then collected from the heated extraction vessel and allowed to cool. Finally, the extract may be concentrated, if necessary, and, as needed, exchanged into a solvent compatible with the cleanup or determinative step being employed.
                    </P>
                    <P>
                        <E T="03">EPA Method 3541:</E>
                         Automated Soxhlet Extraction would also become permissible for PCB extraction under this proposed rule. This method shares many similarities with Manual Soxhlet Extraction (EPA Method 3540C); however, it takes less time and solvent per sample. When performing an Automated Soxhlet Extraction, a moist solid sample (
                        <E T="03">e.g.,</E>
                         soil/sediment samples) may be air-dried and ground prior to extraction or chemically dried with anhydrous sodium sulfate. The prepared sample is then extracted using 1:1 acetone: Hexane in the automated Soxhlet system.
                    </P>
                    <P>
                        <E T="03">EPA is proposing to add EPA Method 3510C:</E>
                         Separatory Funnel Liquid-Liquid Extraction to the PCB Regulations. This method describes a procedure for isolating organic compounds from aqueous samples. The method also describes concentration techniques suitable for preparing the extract for the appropriate determinative methods. A measured volume of sample, usually 1 liter, at a specified pH, is serially extracted with methylene chloride using a separatory funnel. The extract is dried, concentrated (if necessary), and, as necessary, exchanged into a solvent compatible with the cleanup or determinative method to be used.
                    </P>
                    <P>
                        <E T="03">EPA is also proposing to add EPA Method 3520C:</E>
                         Continuous Liquid-Liquid Extraction to the PCB Regulations. This method describes a procedure for isolating organic compounds from aqueous samples. The method also describes concentration techniques suitable for preparing the extract for the appropriate determinative steps. Method 3520 is designed for extraction solvents with greater density than the sample. A measured volume of sample, usually 1 liter, is placed into a continuous liquid-liquid extractor, adjusted, if necessary, to a specific pH, and extracted with organic solvent for 18-24 hours. The extract is dried, concentrated (if necessary), and, as necessary, exchanged into a solvent compatible with the cleanup or determinative method being employed.
                    </P>
                    <P>
                        <E T="03">EPA is also proposing to add EPA Method 3535A:</E>
                         Solid-Phase Extraction (SPE) to the PCB Regulations. This is a procedure for isolating target organic analytes from aqueous samples using solid-phase extraction (SPE) media. It describes conditions for extracting a variety of organic compounds from aqueous matrices that include groundwater, wastewater, and Toxicity Characteristic Leaching Procedure (TCLP) leachates. The extraction procedures are specific to the analytes of interest and vary by group of analytes and type of extraction media.
                    </P>
                    <HD SOURCE="HD3">What is EPA proposing for allowable extraction methods for PCBs?</HD>
                    <P>
                        As stated above, EPA proposes to add the following extraction methods to the 40 CFR part 761 regulations: Method 3541 (Automated Soxhlet Extraction), Method 3545A (Pressurized Fluid Extraction), and Method 3546 (Microwave Extraction) for extraction of PCBs from solid matrices; and Method 3510C (Separatory Funnel Liquid-Liquid Extraction), Method 3520C (Continuous Liquid-Liquid Extraction), 
                        <PRTPAGE P="58735"/>
                        and Method 3535A (Solid-Phase Extraction) for extraction of PCBs from aqueous matrices. EPA is also proposing to add Clean Water Act (CWA) Method 1668C to the PCB regulations. Since it includes both extraction and determinative steps, the discussion of this method is found in 
                        <E T="03">Section III.C. Proposed Updates to Determinative Methods for PCBs.</E>
                         EPA is proposing to allow these methods for use, as applicable, under the following subparts of 40 CFR part 761: Subpart D—Storage and Disposal; Subpart K—PCB Waste Disposal Records and Reports; Subpart M—Determining a PCB Concentration for Purposes of Abandonment or Disposal of Natural Gas Pipeline: Selecting Sites, Collecting Surface Samples, and Analyzing Standard PCB Wipe Samples; Subpart N—Cleanup Site Characterization Sampling for PCB Remediation Waste in Accordance with § 761.61(a)(2); Subpart O—Sampling to Verify Completion of Self-Implementing Cleanup and On-Site Disposal of Bulk PCB Remediation Waste and Porous Surfaces in Accordance with § 761.61(a)(6); Subpart P—Sampling Non-Porous Surfaces for Measurement-Based Use, Reuse, and On-site or Off-Site Disposal Under § 761.61(a)(6) and Determination Under § 761.79(b)(3); Subpart R—Sampling Non-Liquid, Non-Metal PCB Bulk Product Waste for Purposes of Characterization for PCB Disposal in Accordance With § 761.62, and Sampling PCB Remediation Waste Destined for Off-Site Disposal, in Accordance With § 761.61; and Subpart T—Comparison Study for Validating a New Performance-Based Decontamination Solvent under § 761.79(d)(4). These proposed modifications to the 40 CFR part 761 regulations can be found in the regulatory language section towards the end of this notice; the specific sections of the 40 CFR part 761 regulations with these proposed changes include: §§ 761.61(a)(5)(i)(B)(
                        <E T="03">2</E>
                        )(
                        <E T="03">iv</E>
                        ), 761.253, 761.272, 761.292, 761.358, and 761.395.
                    </P>
                    <P>EPA's proposal to add Methods 3541, 3545A and 3546 to the PCB regulations for extraction of PCBs from solid matrices is based on several factors including: Applicability of the method to PCBs, frequency of use in EPA and commercial laboratories and existing data supporting the effectiveness of the methods.</P>
                    <P>
                        EPA proposes to add Method 3541 (Automated Soxhlet Extraction) to the PCB regulations because this method has been validated and approved by EPA to be included in the SW-846 compendium of test methods for use with PCBs. A study titled 
                        <E T="03">Intra-Laboratory Recovery Data for the PCB Extraction Procedure</E>
                         was performed for the validation of Method 3541, which confirms its effectiveness on soils, sediments, sludges and waste solids containing levels of 1 to 50 ppm (parts per million) PCBs.
                        <SU>15</SU>
                        <FTREF/>
                         As part of this study, multi-laboratory accuracy and precision data were obtained for PCBs in soil. Specifically, eight laboratories spiked Aroclors 1254 and 1260 into three portions of 10 g of soil on three non-consecutive days followed by immediate extraction using Method 3541. Six of the laboratories spiked each Aroclor at 5 and 50 ppm and two laboratories spiked each Aroclor at 50 and 500 ppm. The data indicated that Method 3541 is an effective method for extracting PCBs, and these data are listed in Table 8 of Method 8082A, and support EPA's decision to propose including Method 3541 in the PCB regulations.
                        <SU>16</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>15</SU>
                             Stewart, J. “Intra-Laboratory Recovery Data for the PCB Extraction Procedure”; Oak Ridge National Laboratory, Oak Ridge, TN, 37831-6138; October 1981.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>16</SU>
                             U.S. EPA, Method 8082A Polychlorinated Biphenyls (PCBs) by Gas Chromatography. Office of Land and Emergency Management, Office of Resource Conservation and Recovery, Materials Recovery and Waste Management Division (5303P). Washington, DC EPA-820-R-10-004. February 2007.
                        </P>
                    </FTNT>
                    <P>
                        EPA also proposes to add Method 3545A (Pressurized Fluid Extraction) to the PCB regulations because this method has been validated and approved by EPA to be included in the SW-846 compendium of test methods for use with PCBs. A study titled, 
                        <E T="03">Single Laboratory Method Validation Report. Extraction of TCL/PPL (Target Compound List/Priority Pollutant List) OPPs, Chlorinated Herbicides and PCBs using Accelerated Solvent Extraction (ASE),</E>
                         was performed for the validation of Method 3545A, which confirms its effectiveness on solid matrices containing 1 to 1400 ppm PCBs.
                        <SU>17</SU>
                        <FTREF/>
                         Extractions of contaminated soil, river sediment, sewage sludge and oyster tissue were performed, and PCBs were spiked on Fuller's earth (kaolin clay) to determine recovery levels. The overall average recovery of PCBs from all matrices demonstrated that Method 3545A is equivalent in performance to Method 3540C. In addition, a comparison study titled, 
                        <E T="03">Chemical Analysis of Non-Liquid PCBs in Shipboard Solid Materials: Extraction Methods Comparison,</E>
                         was done on electrical cables that were previously found to contain elevated levels of PCBs.
                        <SU>18</SU>
                        <FTREF/>
                         The results of the study indicated that there are generally no significant differences for extractions on shipboard solids using either Method 3540C or Method 3545A. These methods provided comparable results, which provides additional support for EPA's decision to propose including Method 3545A in the PCB regulations. Another study titled, 
                        <E T="03">PCBs in Older Buildings: Measuring PCB Levels in Caulk and Window Glazing Materials in Older Buildings,</E>
                         was performed on 36 samples of caulk and glazing materials.
                        <SU>19</SU>
                        <FTREF/>
                         The average percent recovery values for Aroclor 1254 in the caulk material samples in this study indicate how efficient Method 3545A is for extracting high PCB concentrations from caulk and glazing materials. The results of these three studies support EPA's decision to propose including Method 3545A in the PCB regulations.
                    </P>
                    <FTNT>
                        <P>
                            <SU>17</SU>
                             B. Richter, Ezzell, J., and Felix, D., “Single Laboratory Method Validation Report. Extraction of TCL/PPL (Target Compound List/Priority Pollutant List) OPPs, Chlorinated Herbicides and PCBs using Accelerated Solvent Extraction (ASE).” Document 101124, Dionex Corporation, December 2, 1994).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>18</SU>
                             George, R. Ph.D., Johnston, R. Ph.D. “Chemical Analysis of Non-Liquid PCBs in Shipboard Solid Materials: Extraction Methods Comparison.” Marine Environmental Support Office-NW, Environmental Sciences Branch, January 31, 2008).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>19</SU>
                             Osemwengie, L. and Morgan, J., “PCBs in Older Buildings: Measuring PCB Levels in Caulk and Window Glazing Materials in Older Buildings.” U.S. Environmental Protection Agency, National Exposure Research Laboratory, Exposure Methods and Measurement Division, January 31, 2019).
                        </P>
                    </FTNT>
                    <P>
                        EPA also proposes to add Method 3546 (Microwave Extraction) to the PCB regulations because this method has been validated and approved by EPA to be included in the SW-846 compendium of test methods for use with PCBs. A study titled, 
                        <E T="03">Final Evaluation of US EPA Method 3546: Microwave Extraction, a Microwave Assisted Process (MAP</E>
                        <E T="51">TM</E>
                        <E T="03">) Method for the Extraction of Contaminants Under Closed-Vessel Conditions,</E>
                         was performed for the validation of this method, showing that it is effective for soils, clays, sediments, sludges and solid wastes containing PCBs at levels between 1 to 5,000 ppb (µg/kg).
                        <SU>20</SU>
                        <FTREF/>
                         Data were obtained for PCBs using sediment, natural soils, glass fiber and sand samples in spiked matrices. PCB concentrations varied from 0.2 to 10 ppm, and sample extracts were analyzed by Method 8082A. The recovery data are included in Tables 18-20 of Method 8082A. In addition, a study titled, 
                        <E T="03">
                            Comparison of Soxhlet Extraction, Microwave-Assisted Extraction And Ultrasonic Extraction For The Determination Of PCBs Congeners In Spiked Soils By 
                            <PRTPAGE P="58736"/>
                            Transformer Oil (Askarel),
                        </E>
                         focused on the variation of the extraction quantities for each PCB congener (29 PCBs) with three different extraction methods (Manual Soxhlet Extraction, Microwave Extraction, and Ultrasonic Extraction).
                        <SU>21</SU>
                        <FTREF/>
                         The comparison made between the three methods showed that Microwave Extraction is a suitable alternative to Manual Soxhlet Extraction for the extraction of PCBs in soils, but Ultrasonic Extraction did not give a good recovery. Specifically, the recovery efficiency obtained from Ultrasonic Extraction and Microwave Extraction were (50.67%-78.27%) on the first extraction and (41.15-54.40%) on the second extraction, respectively (see 
                        <E T="03">Section III.B. Proposed Removal or Update of Ultrasonic Extraction (Method 3550B) from the PCB Regulations</E>
                        ). Lastly, a study titled, 
                        <E T="03">Extraction of Organic Pollutants from Solid Samples Using Microwave Energy,</E>
                         used Method 3546 to determine the PCB concentration in two marine sediments, soil, freshly spiked topsoil, spiked and aged topsoil, and four soils from a Superfund site.
                        <SU>22</SU>
                        <FTREF/>
                         The results for the performance of the method on four PCB Aroclors are presented in Table 3 of the study. The recoveries of Aroclor 1016 and 1260 were obtained by Microwave Assisted Extraction (MAE) and were comparable to or higher than those achieved by the conventional extraction techniques (Manual Soxhlet Extraction and Ultrasonic Extraction). The method validation study and additional studies support EPA's decision to propose including Method 3546 (Microwave Extraction) in the PCB regulations.
                    </P>
                    <FTNT>
                        <P>
                            <SU>20</SU>
                             K. Li, J.M.R. Bélanger, M.P. Llompart, R.D. Turpin, R. Singhvi, and J.R.J. Paré, “Final Evaluation of U.S. EPA Method 3546: Microwave Extraction, a Microwave Assisted Process (MAP
                            <E T="51">TM</E>
                            ) Method for the Extraction of Contaminants Under Closed-Vessel Conditions,” Soil and Sediment Contamination, 10 (4), 375-386 (2001).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>21</SU>
                             Halfadji, Ahmed; Touabet Abdelkrim; Badjah-Hadj-Amed, Ahmed-Yacine. 
                            <E T="03">Comparison of Soxhlet Extraction, Microwave-Assisted Extraction and Ultrasonic Extraction for the Determination of PCBs Congeners in Spiked Soils by Transformer Oil (Askarel).</E>
                             International Journal of Advances in Engineering &amp; Technology. Vol. 5, Issue 2, pp. 63-75. Jan. 2013.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>22</SU>
                             Viorica Lopez-Avila, Richard Young, Janet Benedicto, Pauline Ho, and Robert Kim, “Extraction of Organic Pollutants from Solid Samples Using Microwave Energy,” Midwest Research Institute, California (1995).
                        </P>
                    </FTNT>
                    <P>
                        The extraction effectiveness of Method 3540C (Manual Soxhlet Extraction), Method 3541 (Automated Soxhlet Extraction), Method 3545A (Pressurized Fluid Extraction), Method 3546 (Microwave Extraction) and Method 3550B (Ultrasonic Extraction) on soil containing PCBs was compared in: 
                        <E T="03">Comprehensive comparison of classic Soxhlet extraction with Soxtec extraction, ultrasonication extraction, supercritical fluid extraction, microwave assisted extraction and accelerated solvent extraction for the determination of polychlorinated biphenyls in soil.</E>
                        <SU>23</SU>
                        <FTREF/>
                         An overall comparison among the recoveries obtained for the different extraction techniques is shown in Figure 3 of the study. The study concluded that most of the extraction techniques can provide accurate results (including Methods 3541, 3545A, and 3546) when the extraction conditions and procedures are appropriately chosen. In conclusion, EPA finds, based on reasonably available information, that Methods 3541, 3545A, and 3546 are technically sound methods for the extraction of PCBs from solid matrices and provide extraction results that are as accurate as or more accurate than the results using the Manual Soxhlet Extraction method (Method 3540C).
                    </P>
                    <FTNT>
                        <P>
                            <SU>23</SU>
                             Sune Sporring, Søren Bøwadt, Bo Svensmark, Erland Bjorklund. 
                            <E T="03">Comprehensive comparison of classic Soxhlet extraction with Soxtec extraction, ultrasonication extraction, supercritical fluid extraction, microwave assisted extraction and accelerated solvent extraction for the determination of polychlorinated biphenyls in soil.</E>
                             Journal of Chromatography. July 2005.
                        </P>
                    </FTNT>
                    <P>For extraction of PCBs from aqueous matrices, EPA proposes to add Method 3510C (Separatory Funnel Liquid-Liquid Extraction), Method 3520C (Continuous Liquid-Liquid Extraction), and Method 3535A (Solid-Phase Extraction (SPE)) to the PCB regulations to reduce confusion about whether these methods (which are currently listed in Method 8082, the only determinative method currently listed in the PCB regulations) can be used or if an approval is required to use these methods. EPA is proposing to add these methods to the PCB regulations because they have been validated and approved by EPA to be included in the SW-846: Compendium of Test Methods and because they are included in Method 8082 and 8082A as allowable extraction methods for aqueous matrices. EPA finds, based on reasonably available information, that Methods 3510C, 3520C and 3535A are technically sound methods for the extraction of PCBs from aqueous matrices and is requesting comment on the proposed addition of these methods to the PCB regulations under the following sections: §§ 761.61(a)(5)(i)(B)(2)(iv), 761.272, 761.292, 761.358, and 761.395. Note that these aqueous methods would not be added to § 761.253, as it pertains to wipe sampling of surfaces and is not applicable to aqueous materials.</P>
                    <P>EPA is requesting comment on its proposal to add Method 3541, Method 3545A, and Method 3546 to the PCB regulations for extraction of PCBs from solid matrices. Additionally, EPA is requesting comment on adding Method 3510C, Method 3520C and Method 3535A to the PCB regulations for extraction of PCBs from aqueous matrices. EPA also requests the submission of any additional data regarding the use of these methods on samples containing PCBs.</P>
                    <HD SOURCE="HD2">B. Remove Ultrasonic Extraction (Method 3550B) From the PCB Regulations</HD>
                    <HD SOURCE="HD3">Background on This Issue</HD>
                    <P>
                        EPA Method 3550B (Ultrasonic Extraction) is a method currently permissible in the PCB regulations that can be used to extract PCBs from solids, such as soils, sludges and wastes. EPA Method 3550C (Ultrasonic Extraction) is an updated version of Method 3550B and is not currently permissible in the PCB Regulations. For more information on the technical aspects of ultrasonic extraction, see 
                        <E T="03">Section III.A.2. Technical Summary of Relevant Extraction Methods.</E>
                    </P>
                    <P>
                        The text in EPA Method 3550B and Method 3550C includes caveats that ultrasonic extraction may not be as rigorous as other extraction methods and highlights the importance of following the method explicitly. By comparison, this issue is generally not mentioned or highlighted in other SW-846 methods.
                        <SU>24</SU>
                        <FTREF/>
                         Specifically, Method 3550C further emphasizes, beyond what is stated in Method 3550B, the crucial importance of conducting the method properly, in line with the manufacturer's instructions regarding operational settings.
                    </P>
                    <FTNT>
                        <P>
                            <SU>24</SU>
                             Section 1.4 of Method 3550C states, “Because of the limited contact time between the solvent and the sample, ultrasonic extraction may not be as rigorous as other extraction methods for soils/solids. Therefore, it is critical that the method (including the manufacturer's instructions) be followed explicitly, in order to achieve the maximum extraction efficiency. See Sec. 11.0 for a discussion of the critical aspects of the extraction procedure. Consult the manufacturer's instructions regarding specific operational settings.”
                        </P>
                    </FTNT>
                    <P>
                        Previous studies done on the extraction efficiency of ultrasonic extraction methods have provided inconsistent results. Some studies have yielded results from ultrasonic extraction that were equivalent to the results from other extraction methods and, in others, ultrasonic extraction had a lower extraction efficiency.
                        <E T="51">25 26</E>
                        <FTREF/>
                         For 
                        <PRTPAGE P="58737"/>
                        example, in a large study, 20 governmental laboratories and 153 accredited laboratories were provided proficiency samples to extract using either ultrasonic extraction or Manual Soxhlet Extraction and the results were compared. This study showed that “results from laboratories using Soxhlet extraction were significantly more accurate than those obtained using ultrasonic extraction, especially at higher concentrations.” 
                        <E T="51">27 28</E>
                        <FTREF/>
                         The study goes on to state that ultrasonic extraction required “more expertise and care for the method to yield accurate results.” Furthermore, this concern was amplified for difficult to extract media, such as caulk and clay materials, where PCBs are sorbed to the material such that they are very difficult to extract for analysis. Another study tested the effectiveness of several extraction methods on soil containing PCBs, including: Method 3540C, Method 3541, Method 3545A, Method 3546 and Method 3550B.
                        <SU>29</SU>
                        <FTREF/>
                         This study found that using n-hexane/acetone with appropriate choices of extraction time and temperature gave nearly identical data for all methods tested in the study. The study concluded that all extraction techniques tested (including Method 3550B) are capable of providing accurate results when the extraction conditions and procedures are appropriately chosen.
                    </P>
                    <FTNT>
                        <P>
                            <SU>25</SU>
                             Halfadji, Ahmed; Touabet Abdelkrim; Badjah-Hadj-Amed, Ahmed-Yacine. 
                            <E T="03">Comparison of Soxhlet Extraction, Microwave-Assisted Extraction and Ultrasonic Extraction for the Determination of PCBS Congeners in Spiked Soils by Transformer Oil (Askarel).</E>
                             International Journal of Advances in Engineering &amp; Technology. Vol. 5, Issue 2, pp. 63-75. Jan. 2013.
                        </P>
                        <P>
                            <SU>26</SU>
                             McMillin, Richard; Spencer, David; Gregg, Diane; and Nguyen, Neal. 
                            <E T="03">Comparison of Five Soil Extraction Techniques for Pesticide and Semivolatile Analysis.</E>
                             Waste Testing and Quality Assurance Conference. July 1999.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>27</SU>
                             Erickson, M.D. 
                            <E T="03">Analytical Chemistry of PCBs.</E>
                             CRC Press, Inc. 1997.
                        </P>
                        <P>
                            <SU>28</SU>
                             Kimbrough, D.E., R. Chin and J. Wakakuwa. “Industry-Wide Performance in a Pilot Performance Evaluation Sample Program for Hazardous Materials Laboratories. 1. Precision and Accuracy of Polychlorinated Biphenyls. Environmental Science Technology. Vol. 26, Issue 11, pp. 2101-2104. 1992.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>29</SU>
                             Sune Sporring, Søren Bøwadt, Bo Svensmark, Erland Bjorklund. 
                            <E T="03">Comprehensive comparison of classic Soxhlet extraction with Soxtec extraction, ultrasonication extraction, supercritical fluid extraction, microwave assisted extraction and accelerated solvent extraction for the determination of polychlorinated biphenyls in soil.</E>
                             Journal of Chromatography. July 2005.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">What is EPA proposing on this issue?</HD>
                    <P>
                        EPA proposes to remove EPA Method 3550B (Ultrasonic Extraction) from the PCB Regulations. EPA is proposing not to include ultrasonic extraction methods in the PCB regulations because they do not consistently produce reliable results and have a higher potential than other methods to be conducted improperly. The PCB regulatory sections which would be affected by this proposal include §§ 761.61(a)(5)(i)(B)(
                        <E T="03">2</E>
                        )(
                        <E T="03">iv</E>
                        ), 761.253, 761.272, 761.292, 761.358, and 761.395.
                    </P>
                    <P>Previous studies arrived at different conclusions regarding the effectiveness of ultrasonic extraction. The level of uncertainty raised by these studies causes concerns, especially for difficult to extract media, such as caulk and clay materials, where PCBs are sorbed to the material such that they are very difficult to extract for analysis. Compounding this, the importance of following the method explicitly is uniquely highlighted in the ultrasonic extraction methods, suggesting that the potential of conducting ultrasonic extraction improperly is higher relative to other methods found in SW-846. Therefore, EPA finds, based on reasonably available information, that ultrasonic extraction is not a reliably effective extraction method and is proposing to remove it from the PCB regulations.</P>
                    <P>EPA also believes that removing ultrasonic extraction from the PCB regulations would not result in increased burden as many laboratories do not solely use ultrasonic extraction for PCB samples for several reasons, including difficulty in meeting quality assurance/quality control (QA/QC) requirements, problems with low recoveries depending on the sample matrix, and the fact that Method 3550B may be labor intensive relative to other commonly used methods, such as Method 3545A. In addition, EPA believes that if ultrasonic extraction were removed from the PCB regulations, laboratories would likely use other extraction methods with associated equipment they likely already have available. See the Economic Assessment for a full analysis of the costs and cost savings.</P>
                    <P>EPA requests comment on the impacts of removing ultrasonic extraction from the PCB regulations due to the conflicting data and the challenge of conducting this method appropriately to obtain reliable results. Any additional information or data regarding the efficiency of Methods 3550B and 3550C would help EPA better evaluate them for inclusion in the PCBs regulations.</P>
                    <HD SOURCE="HD2">C. Add Determinative Methods for the PCB Regulations</HD>
                    <HD SOURCE="HD3">Background on This Issue</HD>
                    <P>
                        Currently, the PCB regulations list Method 8082 (Polychlorinated Biphenyls (PCBs) by Gas Chromatography) as the only determinative method for PCB samples.
                        <SU>30</SU>
                        <FTREF/>
                         The only exception in the PCB regulations is at § 761.60(g)(1)(iii) where it states that “[a]ny gas chromatographic method that is appropriate for the material being analyzed may be used” and then suggests several optional determinative methods.
                        <SU>31</SU>
                        <FTREF/>
                         However, this section in the PCB regulations is restricted to samples of mineral oil dielectric fluid (MODEF) and waste oil (see §§ 761.60(g)(1) and 761.60(g)(2)). Currently, all other samples must be analyzed using EPA Method 8082, and any alternative determinative method would require EPA approval. In addition, updated (
                        <E T="03">i.e.,</E>
                         Method 8082A) or modified versions of 8082 may not be used, since they are not explicitly stated in the PCB regulations. While EPA has not received any significant concerns from the regulated community regarding the availability of determinative methods, EPA has investigated additional determinative methods to include in this rulemaking to provide a greater number of technically sound options for the regulated community. Additional determinative methods may reduce the administrative burden on the Agency by reducing the number of approvals processed for alternative methods.
                    </P>
                    <FTNT>
                        <P>
                            <SU>30</SU>
                             U.S. EPA, Method 8082 Polychlorinated Biphenyls (PCBs) By Gas Chromatography. Office of Land and Emergency Management, Office of Resource Conservation and Recovery, Materials Recovery and Waste Management Division (5303P). Washington, DC. December 1996.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>31</SU>
                             The regulatory text at § 761.60(g)(1)(iii) lists the following methods: “. . . EPA Method 608, “Organochlorine Pesticides and PCBs” at 40 CFR part 136, Appendix A;” EPA Method 8082, “Polychlorinated Biphenyls (PCBs) by Capillary Column Gas Chromatography” of SW-846, “OSW Test Methods for Evaluating Solid Waste,” which is available from NTIS; and ASTM Standard D-4059, “Standard Test Method for Analysis of Polychlorinated Biphenyls in Insulating Liquids by Gas Chromatography,” which is available from ASTM.”
                        </P>
                    </FTNT>
                    <P>Additionally, the previously mentioned methods referenced in § 761.60(g)(1)(iii) are outdated and EPA believes that they should be updated to the most current versions. By updating these method references, EPA is not requiring that only the new specifically referenced methods be used, as § 761.60(g)(1)(iii) provides that “[a]ny gas chromatographic method that is appropriate for the material being analyzed may be used.” EPA believes this update will avoid confusion by referencing the most up-to-date methods while still allowing flexibility in this regulatory provision.</P>
                    <HD SOURCE="HD3">What is EPA proposing on this issue?</HD>
                    <P>
                        EPA proposes to add three determinative methods to the PCB regulations: Method 8082A (Polychlorinated Biphenyls (PCBs) By Gas Chromatography), Method 8275A (Semivolatile Organic Compounds (PAHs And PCBs) In Soils/Sludges and Solid Wastes Using Thermal Extraction/Gas Chromatography/Mass Spectrometry (TE/GC/MS)), and Method 1668C (Chlorinated Biphenyl Congeners in Water, Soil, Sediment, Biosolids and 
                        <PRTPAGE P="58738"/>
                        Tissue by HRGC/HRMS).
                        <E T="51">32 33 34</E>
                        <FTREF/>
                         The PCB regulatory sections affected by this change include §§ 761.61(a)(5)(i)(B)(
                        <E T="03">2</E>
                        )(
                        <E T="03">iv</E>
                        ), 761.253, 761.272, 761.292, 761.358, and 761.395.
                    </P>
                    <FTNT>
                        <P>
                            <SU>32</SU>
                             U.S. EPA, Method 8082A Polychlorinated Biphenyls (PCBs) By Gas Chromatography. Office of Land and Emergency Management, Office of Resource Conservation and Recovery, Materials Recovery and Waste Management Division (5303P). Washington, DC. February 2007.
                        </P>
                        <P>
                            <SU>33</SU>
                             U.S. EPA, Method 8275A Semivolatile Organic Compounds (PAHs And PCBs) In Soils/Sludges and Solid Wastes Using Thermal Extraction/Gas Chromatography/Mass Spectrometry (TE/GC/MS). Office of Land and Emergency Management, Office of Resource Conservation and Recovery, Materials Recovery and Waste Management Division (5303P). Washington, DC. December 1996.
                        </P>
                        <P>
                            <SU>34</SU>
                             U.S. EPA, Method 1668 Chlorinated Biphenyl Congeners in Water, Soil, Sediment, Biosolids, and Tissue by HRGC/HRMS. Office of Land and Emergency Management, Office of Water, Office of Science and Technology, Engineering and Analysis Division (4303T). Washington, DC. EPA-820-R-10-005. April 2010.
                        </P>
                    </FTNT>
                    <P>
                        As mentioned in the preceding section, EPA also proposes to update the outdated referenced methods in § 761.60(g)(1)(iii). EPA Method 608 would be updated to EPA Method 608.3, and EPA Method 8082 would be updated to EPA Method 8082A.
                        <SU>35</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>35</SU>
                             U.S. EPA, Method 608.3 Organochlorine Pesticides and PCBs by GC/HSD. Office of Water, Office of Science and Technology, Engineering and Analytical Division (4303T). Washington, DC. EPA-820-R-10-004. December 2016.
                        </P>
                    </FTNT>
                    <P>EPA proposes to add Method 8082A to the PCB regulations because Method 8082A has been validated and included in the SW-846 compendium of test methods and Method 8082A is only a minor revision to the method (Method 8082) currently allowed in the PCB regulations. Method 8082A includes updated references/validation studies, formatting changes and other various minor changes, but overall is similar to Method 8082. Method 8082A can determine the concentrations of PCBs as Aroclors or as individual PCB congeners in extracts from solid, tissue, and aqueous matrices, using open-tubular, capillary columns with electron capture detectors (ECD) or electrolytic conductivity detectors (ELCD). If appropriate sample extraction and cleanup procedures are employed, Method 8082A can work for other matrices, such as oils and wipe samples. Note that Method 8082A would not replace Method 8082, and that both methods would be available in the PCB regulations.</P>
                    <P>
                        EPA also proposes to add Method 8275A (Semivolatile Organic Compounds (PAHs and PCBs) In Soils/Sludges and Solid Wastes Using Thermal Extraction/Gas Chromatography/Mass Spectrometry (TE/GC/MS)) to the PCB regulations for several reasons, including the fact that this method has been validated and approved by EPA to be included in the SW-846 compendium of test methods. Method 8275A is a thermal extraction capillary GC/MS procedure for the rapid quantitative determination of targeted PCBs and PAHs in soils, sludges and solid wastes. The validation data presented in the method demonstrates that several PCB congeners can be reliably analyzed using this method.
                        <SU>36</SU>
                        <FTREF/>
                         This method is different from the other methods because PCBs are extracted, without the use of any solvent, by a process of heating a stream of inert gas to a temperature that is adequate to desorb the PCBs out of the sample. The desorbed PCBs are then fed directly into an analyzer (
                        <E T="03">e.g.,</E>
                         GS/MS) to determine the PCB concentration. A separate extraction method may not be required if using Method 8275A and, since no solvent is used, there is less waste produced and fewer cleanup steps involved. EPA finds, based on reasonably available information, that Method 8275A is appropriate for inclusion in the PCB regulations and since this method does not require solvent, it would advance Agency priorities on the use of greener technologies.
                        <SU>37</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>36</SU>
                             Worden, R., “Method 8275A: Quantitative Addendum For SW-846 Method 8275”, Research report to the U.S. Environmental Protection Agency; Ruska Laboratories, Inc., Houston, TX, 1993.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>37</SU>
                             
                            <E T="03">https://www.epa.gov/sites/production/files/2015-10/documents/oswer_greencleanup_principles.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        EPA also proposes to add Method 1668C, Chlorinated Biphenyl Congeners in Water, Soil, Sediment, Biosolids and Tissue by HRGC/HRMS, developed by EPA's Office of Water for use under the Clean Water Act (CWA), to the PCB regulations. This method determines PCB congeners in environmental samples by isotope dilution and internal standard high-resolution gas chromatography/high-resolution mass spectrometry (HRGC/HRMS) for use in wastewater, surface water, soil, sediment, biosolids and tissue matrices. Method 1668C is different relative to many methods in SW-846, in that it is a comprehensive method where cleanup, extraction and determinative steps are all within Method 1668C. In SW-846, these steps are usually separated into multiple different methods. Additionally, Method 1668C allows for certain modifications to be made without EPA review provided that all performance criteria are met as described within the method. EPA finds, based on reasonably available information, that Method 1668C is appropriate for inclusion in the PCB regulations because the validation data presented in the method demonstrate that several PCB congeners can be reliably analyzed using this method.
                        <SU>38</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>38</SU>
                             U.S. EPA, Method 1668A Interlaboratory Validation Study Report. Office of Water, Office of Science and Technology, Engineering and Analytical Division (4303T). Washington, DC. EPA-820-R-10-004. March 2010.
                        </P>
                    </FTNT>
                    <P>
                        EPA considered other determinative methods but chose against proposing those which were judged to be too broad, too prescriptive, or not robust enough to accurately determine the PCB concentration. For example, EPA Method 608.3 is prescribed for analyzing only Aroclors, which is why it will only be allowed under § 761.60(g)(1)(iii) as this section relates to chemical analysis of mineral oil dielectric fluid. This method was a concern for PCB remediation waste because spilled PCBs become `weathered' over time. The weathering process is due to repeated wetting and drying cycles, which causes the PCBs to adsorb to the material and degrade into congeners that are different from when the PCBs were manufactured as Aroclors. As a result, the PCB concentration may not be accurately determined by a method that only analyzes for Aroclors. Another example is Method 8270E, which contains a limitation that states, “[i]n most cases, this method is not appropriate for the quantitation of multicomponent analytes (
                        <E T="03">e.g.,</E>
                         polychlorinated biphenyls (PCBs) as Aroclors, technical toxaphene, chlordane, etc.) because of limited sensitivity for these analytes or potential for measurement bias using gas chromatograph/mass spectrometer (GC/MS) technology.” 
                        <SU>39</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>39</SU>
                             U.S. EPA, Method 8270E Semivolatile Organic Compounds by Gas Chromatography/Mass Spectrometry. (GC/MS). Office of Land and Emergency Management, Office of Resource Conservation and Recovery, Materials Recovery Waste Management Division (5303P). Washington, DC. June 2018.
                        </P>
                    </FTNT>
                    <P>
                        Other methods considered but not included in today's proposal were very general and were designed for `semivolatile' compounds rather than specifically for PCB analysis. After reviewing these methods, EPA found that the validation studies did not include PCBs and thus EPA is unable to determine the effectiveness of these methods for PCB samples. Method 680 was also considered but this method has not been maintained, reviewed, or updated regularly, like those found in the SW-846 compendium.
                        <SU>40</SU>
                        <FTREF/>
                         As a result, this method is over 30 years old and its 
                        <PRTPAGE P="58739"/>
                        reliability is unclear. Although EPA is not proposing Method 608.3 (except for use in the chemical analysis of mineral oil dielectric fluids under § 761.60(g)(1)(iii)), Method 8270E, or Method 680, EPA notes that a person may either conduct a Subpart Q comparison study or submit an appropriate application (
                        <E T="03">i.e.,</E>
                         §§ 761.61(c), 761.62(c) or 761.79(h)) requesting to use or modify a determinative method for their project.
                    </P>
                    <FTNT>
                        <P>
                            <SU>40</SU>
                             U.S. EPA, Method 680 Determination of Pesticides and PCBs in Water and Soil/Sediment by Gas Chromatography/Mass Spectrometry (GC/MS). Office of Research and Development. Cincinnati, OH. November 1985.
                        </P>
                    </FTNT>
                    <P>EPA is seeking comment on its proposal to add three determinative methods (Method 8082A, Method 1668C, and Method 8275A) to the PCB regulations. EPA also requests any additional information that may supplement or refute the existing support for EPA's findings for this proposal.</P>
                    <HD SOURCE="HD2">D. Revise Performance-Based Disposal Under § 761.61(b)</HD>
                    <HD SOURCE="HD3">Background on the Issue</HD>
                    <P>Currently, there are three options for addressing PCB remediation waste, listed in § 761.61 under paragraphs (a), (b) and (c). Section 761.61(b) (entitled “performance-based disposal”) prescribes disposal methods for liquid and non-liquid PCB remediation waste but does not explicitly require or refer to cleanup requirements or cleanup levels in the regulations. Specifically, section 761.61(b) simply states that any person disposing of liquid (§ 761.61(b)(1)) and non-liquid (§ 761.61(b)(2)) PCB remediation waste shall do so by one of the TSCA-approved disposal methods listed therein. Section 761.61(b) does not currently include provisions for site cleanup. The other PCB remediation waste options in § 761.61 are “self-implementing on-site cleanup and disposal of PCB remediation waste” in § 761.61(a) and “risk-based disposal approval” in § 761.61(c). Section 761.61(a) describes in detail the requirements for notification, site characterization, cleanup levels, cleanup verification, disposal options and more. Section 761.61(c) allows the site owner to apply for a risk-based approval to “sample, cleanup, or dispose of PCB remediation waste in a manner other than prescribed in paragraphs (a) or (b).” The language of section 761.61(b) thus does not conform to the other two options in that the provision does not state the removal requirements of PCB remediation waste at any specified concentration nor does it provide for procedures to demonstrate that on-site cleanup is complete.</P>
                    <P>
                        Prior to this rulemaking, EPA had stated in guidance related to § 761.61(b) that to be completely unregulated for disposal off-site without an approval from EPA, waste must contain &lt;1 ppm PCBs, and that concentration must not be the result of dilution during remediation (
                        <E T="03">i.e.,</E>
                         by mixing with clean soil during excavation).
                        <SU>41</SU>
                        <FTREF/>
                         Similarly, if someone were to use § 761.61(b) for disposal of waste, but leave materials on-site &gt; 1 ppm, they would still have TSCA obligations for those remaining materials.
                        <SU>42</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>41</SU>
                             PCB Q&amp;A Manual. June 2014. Pg. 91. 
                            <E T="03">https://www.epa.gov/sites/production/files/2015-08/documents/qacombined.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>42</SU>
                             
                            <E T="03">https://www.epa.gov/pcbs/managing-remediation-waste-polychlorinated-biphenyls-pcbs-cleanups.</E>
                        </P>
                    </FTNT>
                    <P>
                        While EPA's regulatory text and preamble statements refer to §§ 761.61(a), (b), and (c) as three alternatives for PCB cleanup and disposal, the absence of cleanup provisions, such as cleanup levels and sampling requirements, in § 761.61(b) could make it challenging for site owners to know when EPA would agree that on-site cleanup is complete and the site is authorized for use under § 761.30(u).
                        <E T="51">43 44</E>
                        <FTREF/>
                         Clear regulatory requirements may be warranted as EPA estimates that 50 to 60 million kg of PCB remediation waste are generated at 430 to 460 sites cleaned up under § 761.61(b) each year.
                        <SU>45</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>43</SU>
                             The preamble to the 1994 proposed PCB Megarule (59 FR 62796).
                        </P>
                        <P>
                            <SU>44</SU>
                             40 CFR 761.61, introductory paragraph.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>45</SU>
                             Manifest data from 2018 and 2019 was analyzed to estimate the volume of waste and number of sites cleaned up under § 761.61(b).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">EPA Proposal on This Issue</HD>
                    <P>EPA proposes to amend § 761.61(b) (performance-based disposal) to add performance-based cleanup standards, while maintaining this option as one which does not require prior EPA approval and thus remains an expedient option for those entities removing PCB remediation waste from the site. Specifically, EPA is proposing to amend § 761.61(b) to include explicit conditions for on-site remediation and cleanup of PCB remediation waste. This specification includes: (1) Establishing cleanup levels for sites remediated under § 761.61(b) performance-based cleanup; (2) limiting applicability of this option to sites that are not near sensitive populations or environments; (3) verification sampling; (4) recordkeeping requirements; (5) post-cleanup notification; and (6) allowing for disposal of PCB remediation waste in RCRA Subtitle C permitted landfills. After fulfilling the conditions of performance-based cleanup and disposal, the site would then be authorized for use under § 761.30(u).</P>
                    <P>
                        While the proposed conditions for performance-based cleanup will require additional effort on the part of site owners, the proposed conditions will also provide site owners confidence that they are satisfying the regulatory requirements. As always, failure to properly characterize PCBs on site is not a defense for noncompliant cleanup and disposal. Liability for ensuring compliance with § 761.61(b), performance-based cleanup and disposal, lies with the responsible party. In addition, while the revisions to § 761.61(b) are designed to be fully self-implementing, if the remediating party has questions as to whether its site qualifies to be cleaned up under § 761.61(b)(1)(i) of this provision, it would be in the remediating party's best interest, from a compliance assurance perspective, to contact the appropriate EPA Regional PCB Coordinator prior to commencing the cleanup and disposal activities. See the EPA PCB website for a list of the EPA Regional PCB Coordinators 
                        <E T="03">www.epa.gov/pcbs/program-contacts.</E>
                    </P>
                    <P>
                        First, EPA proposes to establish cleanup levels for sites remediated under a § 761.61(b) performance-based cleanup. Currently, the regulations do not reference a specific cleanup level. The 1994 preamble provides that § 761.61(b) “could be used where all PCB remediation waste would be removed from the environment, or where remediation levels were established elsewhere in these rules.” 
                        <SU>46</SU>
                        <FTREF/>
                         In guidance, EPA has interpreted “all PCB remediation waste” to mean PCB remediation waste at &gt;1 ppm PCBs.
                        <SU>47</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>46</SU>
                             The preamble to the 1994 proposed PCB Megarule (59 FR 62796).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>47</SU>
                             Managing Remediation Waste From Polychlorinated Biphenyls (PCBs) Cleanups 
                            <E T="03">https://www.epa.gov/pcbs/managing-remediation-waste-polychlorinated-biphenyls-pcbs-cleanups.</E>
                        </P>
                    </FTNT>
                    <P>
                        Identifying a numerical cleanup level in regulations will help responsible parties understand the circumstances under which they could expect to have no further cleanup responsibility at the site under § 761.61(b). EPA is therefore proposing to incorporate the following cleanup levels directly into § 761.61(b): ≤1 ppm for bulk PCB remediation waste and porous surfaces; the concentrations specified in § 761.79(b)(1) and (2) for liquids; and the concentrations specified in § 761.79(b)(3) for nonporous surfaces. EPA notes that the cleanup levels for liquids and nonporous surfaces are already performance-based decontamination standards, so materials decontaminated to those levels are authorized for use under § 761.79 and § 761.30(u). Additionally, the cleanup level for bulk remediation waste and 
                        <PRTPAGE P="58740"/>
                        porous surfaces is already used in § 761.61(a) as the most stringent cleanup level (with certain exceptions accommodated in the proposal as described below), corresponding to the cleanup level for a high occupancy area without further conditions. See proposed § 761.61(b)(1)(ii).
                    </P>
                    <P>
                        Second, EPA proposes an applicability provision be included in the § 761.61(b) performance-based cleanup to exclude the provision's use at sites with specific characteristics that merit additional consideration by EPA. In the 1998 Megarule, EPA established that certain types of sensitive environments and populations would not be well-served by the cleanup levels prescribed in § 761.61(a)(4) and therefore excluded these locations from the applicability of § 761.61(a). See § 761.61(a)(1). In addition, the regulation identifies certain types of sites that, while subject to § 761.61(a), may call for more stringent cleanup levels. See § 761.61(a)(4)(vi). Since the proposed performance-based cleanup would not require consultation with EPA, EPA proposes a list of objective characteristics that would exclude a site from using performance-based cleanup standards, which largely mirrors the applicability section in § 761.61(a)(1) and the characteristics in §§ 761.61(a)(4)(vi), 761.120(a)(2), and 761.120(d)(2)(iv) of sites that may require more stringent cleanup levels or site-specific determinations. Additionally, the proposed criteria in § 761.61(b)(1)(A) exclude sites where PCB remediation waste is found within the 100-year floodplain, which would allow EPA to give additional consideration to the protection of waterways by handling the cleanup through § 761.61(a) and/or § 761.61(c). Responsible parties should be able to independently evaluate their site and determine whether performance-based cleanup would be applicable. EPA's regional PCB Coordinators are available to provide site-specific guidance, but such consultation should not be needed to apply the regulations to a site.
                        <SU>48</SU>
                        <FTREF/>
                         See proposed § 761.61(b)(1)(i)(A). In the event that a responsible party is precluded from using § 761.61(b) under EPA's proposed applicability criteria, they can choose to conduct their cleanup under one of the other two options, 
                        <E T="03">i.e.,</E>
                         §§ 761.61(a) or 761.61(c).
                    </P>
                    <FTNT>
                        <P>
                            <SU>48</SU>
                             Contact information for PCB regional coordinators. 
                            <E T="03">https://www.epa.gov/pcbs/program-contacts.</E>
                        </P>
                    </FTNT>
                    <P>Third, EPA proposes to require verification sampling in accordance with the PCB regulations to ensure that the proposed cleanup levels have been met. Currently, EPA expects that verification sampling is already conducted by responsible parties using § 761.61(b) for site cleanup to ensure that PCB remediation waste is removed. Under this proposal, EPA is specifying that verification sampling be conducted in accordance with Subpart O for bulk PCB remediation waste and porous surfaces, Subpart P or § 761.79(b)(3)(i) for nonporous surfaces, and § 761.269 for liquid remediation waste. EPA is also proposing, similar to the cleanup option under § 761.61(a), that the concentration in every required sample analysis result must be below the specified cleanup levels for the cleanup to be complete. See proposed § 761.61(b)(1)(iii).</P>
                    <P>Fourth, EPA is also proposing to incorporate explicit recordkeeping requirements into performance-based cleanup. Currently, responsible parties using § 761.61(b) are subject to the applicable recordkeeping requirements in § 761.180(a) for PCB remediation waste shipped off-site. Under the proposed provisions for performance-based cleanup, responsible parties would need to follow the recordkeeping requirements in the PCB Spill Cleanup Policy at § 761.125(c)(5) in addition to any applicable requirements in § 761.180(a). These requirements are also required for self-implementing cleanups conducted under § 761.61(a) (see § 761.61(a)(9)). Nine specific items would be documented in the records, and records would be required to be maintained for five years. While the proposed requirements would present a small additional burden to responsible parties, EPA believes that recordkeeping would benefit responsible parties by allowing them to demonstrate to regulators, prospective property purchasers, or insurers that site cleanup was completed according to the conditions in § 761.61(b). See the Economic Assessment for a full analysis of the costs. See proposed § 761.61(b)(1)(iv).</P>
                    <P>Fifth, EPA proposes to incorporate a post-cleanup notification into the proposed performance-based cleanup provisions. Under performance-based cleanup and disposal, sites would be remediated without EPA involvement. While EPA understands the value of a site remediation option that is self-directed and expedient, it is also reasonable to expect that regulators need a way to evaluate performance to ensure the conditions, such as cleanup levels, were met. EPA is proposing to require responsible parties to send a notification to EPA within 14 days of the final shipment of waste offsite for disposal. The proposed notification would require information about the site and point of contact, the disposal facility and waste shipments, and a summary of the required records. The notification would also include a certification, as defined in § 761.3, from the responsible party. This basic notification would only include information that EPA is proposing be kept under the recordkeeping provision, and thus should not present an additional significant burden on the responsible party. See the Economic Assessment and Information Collection Request for specific estimates. EPA, state, tribal and local environmental agencies could then use the proposed notification as way to maintain oversight.</P>
                    <P>
                        Sixth, EPA proposes to add a RCRA Subtitle C landfill disposal option for non-liquid PCB remediation waste under § 761.61(b). RCRA Subtitle C landfills are already allowed to be used for the disposal of bulk PCB remediation waste under § 761.61(a)(5)(i)(B)(2)(iii) and for PCB bulk product waste under § 761.62(a)(3). EPA has previously stated in the preamble to the final 1998 PCB Disposal Amendments, “EPA added RCRA Subtitle C landfills as a disposal option for PCB bulk product waste because they are designed and operated in the same manner as TSCA chemical waste landfills.” 
                        <SU>49</SU>
                        <FTREF/>
                         EPA has not received any information in the intervening two decades that would suggest otherwise. Since EPA has already determined that RCRA Subtitle C landfills are protective for bulk product waste, which typically contain very high concentrations of PCBs, the Agency finds its proposal to extend the use of RCRA Subtitle C landfills for non-liquid PCB remediation waste under § 761.61(b) to be reasonable. By adding these landfills to the list of allowable disposal options for certain PCB remediation wastes, EPA anticipates that the transportation costs will decrease, as the distance to the closest allowable disposal option diminishes. Furthermore, the disposal cost per ton of non-liquid, nonhazardous PCB waste is generally lower at RCRA Subtitle C landfills than it is at TSCA chemical waste landfills. See the Economic Assessment for more information on the estimated costs. EPA is requesting comment on the proposal to add RCRA 
                        <PRTPAGE P="58741"/>
                        Subtitle C landfills to the list of allowable disposal options for non-liquid PCB remediation waste under § 761.61(b).
                    </P>
                    <FTNT>
                        <P>
                            <SU>49</SU>
                             pg 35410: Megarule Preamble. 1998 “In response to comments seeking consistency with PCB remediation waste disposal, EPA added RCRA Subtitle C landfills as a disposal option for PCB bulk product waste because they are designed and operated in the same manner as TSCA chemical waste landfills (see § 761.62(a)(3) of the regulatory text). 
                            <E T="03">https://www.govinfo.gov/content/pkg/FR-1998-06-29/pdf/98-17048.pdf.</E>
                        </P>
                    </FTNT>
                    <P>Finally, EPA proposes a change to § 761.125(a)(2) of the PCB Spill Cleanup Policy to ensure that the addition of RCRA Subtitle C landfills to § 761.61(b) does not affect the Spill Cleanup Policy. Currently, the PCB Spill Cleanup Policy calls for disposal of cleanup debris and non-liquid materials in accordance with the provisions of Subpart D. The only Subpart D disposal options currently available for PCB remediation waste managed under the Spill Cleanup Policy are the options under § 761.61(b). Under the current language of the Spill Cleanup Policy, the proposed addition of RCRA Subtitle C landfills to § 761.61(b) would have the effect of adding those landfills as an option for disposal under the Spill Cleanup Policy. Expanding the disposal options available under the Spill Cleanup Policy is not an objective of this rulemaking, and is outside the scope of this rulemaking. Therefore, EPA is proposing to revise the language in the Policy to specify that only disposal facilities with TSCA approvals issued under Subpart D of the PCB regulations may be used for disposal of cleanup debris and materials generated under the Spill Cleanup Policy. This change to the Spill Cleanup Policy is not substantive; rather, it maintains the disposal options currently available under the Policy.</P>
                    <P>
                        EPA notes that the above proposed changes would not impact a responsible party's ability 
                        <SU>50</SU>
                        <FTREF/>
                         to pair disposal under § 761.61(b) with on-site cleanup under § 761.61(a), proposed § 761.61(b), § 761.61(c), or § 761.77 (state-led cleanup under a coordinated approval). The proposed regulatory text explicitly preserves the ability to use § 761.61(b) solely as a disposal provision. See proposed introductory paragraph in § 761.61(b).
                    </P>
                    <FTNT>
                        <P>
                            <SU>50</SU>
                             1994 proposed PCB Disposal Amendments (59 FR 62796).
                        </P>
                    </FTNT>
                    <P>EPA requests comment on its proposed changes to § 761.61(b), as well as how often it is currently being used in comparison to EPA's estimate. Additionally, EPA is requesting comment on the option of requiring a pre-cleanup notification in § 761.61(b), in addition to the proposed changes described above. The pre-cleanup notification would include basic information such as name, contact information, site location and proximity to areas identified in § 761.61(b)(1)(i), initial site characterization, and planned remedial action(s). EPA sees value in receiving such a notification in terms of providing EPA with an opportunity to conduct compliance assistance, increase public transparency, and minimize the need for the use of enforcement tools after the cleanup and disposal are complete. EPA also recognizes that pre-cleanup notification would pose additional reporting burden and that such burden must be balanced with the self-implementing nature of § 761.61(b). If a pre-cleanup notification were incorporated into § 761.61(b), the responsible party would not be required to wait for a response or receive approval from EPA and could begin the planned remedial action(s) immediately. EPA requests comment on the impacts of a pre-cleanup notification and whether or not to include the notification in the final rulemaking.</P>
                    <HD SOURCE="HD2">E. Remove Regulatory Provision Allowing Disposal of PCB Bulk Product Waste as Roadbed</HD>
                    <HD SOURCE="HD3">Background on the Issue</HD>
                    <P>
                        EPA established a provision allowing for disposal of PCB bulk product waste as roadbed in 1998 (63 FR 35412 (June 29, 1998)). In the preamble for that rule, EPA stated that “[b]ecause these disposal options have been restricted to materials that do not leach and because other potential routes of exposure have been controlled, EPA has concluded that the risk from these disposal options is the practical equivalent of disposal in a landfill as required in § 761.62(b)(1), and therefore that this risk is not unreasonable.” Since 1998, the assumption that PCBs do not migrate from bulk product waste has been proven incorrect in many scenarios.
                        <SU>51</SU>
                        <FTREF/>
                         For example, studies show that caulk containing PCBs degrades, releasing PCBs to the air, stormwater, and adjacent soil.
                        <SU>52</SU>
                        <FTREF/>
                         Considering these studies, EPA questions whether potential leaching of PCBs from bulk product waste used as roadbed could lead to environmental releases of PCBs and potential exposures to humans and wildlife. As a result, EPA no longer has a basis to support the determination of no unreasonable risk of injury to health or the environment that the Agency made in 1998. EPA further believes that this disposal option is not widely used.
                    </P>
                    <FTNT>
                        <P>
                            <SU>51</SU>
                             Eero Priha, Sannamari Hellman, Jaana Sorvari, PCB contamination from polysulphide sealants in residential areas—exposure and risk assessment, Chemosphere, Volume 59, Issue 4, 2005, Pages 537-543. 
                            <E T="03">https://www.sciencedirect.com/science/article/pii/S0045653505001074.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>52</SU>
                             Luca Rossi, Luiz de Alencastro, Thomas Kupper, Joseph Tarradellas, Urban stormwater contamination by polychlorinated biphenyls (PCBs) and its importance for urban water systems in Switzerland, Science of The Total Environment, Volume 322, Issues 1-3, 2004, Pages 179-189. 
                            <E T="03">https://www.sciencedirect.com/science/article/pii/S0048969703003619.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">What is EPA proposing on this issue?</HD>
                    <P>EPA proposes to remove the option currently provided for in § 761.62(d)(2) to dispose of PCB bulk product waste under asphalt as roadbed because the Agency cannot, at this time, determine the practice presents no unreasonable risk of injury to health or the environment. EPA further believes that this disposal option is not widely used and thus removing it from the regulations is not likely to present significant burden to the regulated community. EPA is seeking comment on the proposal to remove this option from the regulations. In particular, EPA is interested in any concrete information about the use of PCB bulk product waste as roadbed, especially reports of specific placements indicating that the practice is more widely used than EPA believes. EPA is also interested in any studies regarding the potential for the release of PCBs from the roadbed.</P>
                    <HD SOURCE="HD2">F. Add Flexible Provisions for Emergency Situations</HD>
                    <HD SOURCE="HD3">Background on the Issue</HD>
                    <P>The TSCA PCB Spill Cleanup Policy was first published on April 2, 1987 (52 FR 10688), codified at part 761, subpart G, and applies only to certain releases of PCBs occurring after May 4, 1987. The TSCA PCB Spill Cleanup Policy requires cleanup of PCBs to different levels depending upon spill location, the potential for exposure to residual PCBs remaining after cleanup, the concentration of PCBs initially spilled (high concentration or low), and the nature and size of the population potentially at risk of exposure to residual PCBs. Thus, the Policy applies the most stringent requirements for PCB spill cleanup to non-restricted access areas where there is a greater potential for human exposures to spilled PCBs. The Policy applies less stringent requirements for cleanup of PCB spills in restricted access areas where the nature and degree of human contact present a lower potential for significant exposure. Finally, even less stringent requirements apply to restricted access areas where there is little potential for human exposures (59 FR 62793).</P>
                    <P>
                        When the spilled material contains 50 to 500 ppm PCBs and the total quantity of material spilled involves less than 1 lb of PCBs, the Policy allows for cleanup in accordance with procedural performance requirements (
                        <E T="03">i.e.,</E>
                         double wash/rinse for solid surfaces and removal of visible traces plus a 1-foot lateral boundary for soil and other 
                        <PRTPAGE P="58742"/>
                        ground media provided that the minimum depth of excavation is 10 inches) rather than requiring sampling to verify that numerical cleanup standards have been met. When the spilled material has greater than 500 ppm PCBs or the total quantity of material spilled involves more than 1 lb of PCBs by weight, the Policy provides numerical cleanup standards based on the accessibility of the area and the potential for human exposure. Post-cleanup sampling is required to verify that the cleanup standards have been met. The Policy requires reporting to EPA within 24 hours for spills that directly contaminate sensitive areas, such as drinking water supplies or grazing lands, or where a spill exceeds 10 pounds of PCBs by weight. See § 761.125(a)(1) for details.
                    </P>
                    <P>
                        EPA may allow less stringent or alternative requirements based upon site-specific considerations (§ 761.120(a)(4)). EPA has used this provision to issue storm-specific guidance in Regions 4 and 6 for Hurricanes Katrina (2005),
                        <SU>53</SU>
                        <FTREF/>
                         Harvey (2017),
                        <SU>54</SU>
                        <FTREF/>
                         Irma (2017),
                        <SU>55</SU>
                        <FTREF/>
                         Florence (2018),
                        <SU>56</SU>
                        <FTREF/>
                         Michael (2018),
                        <SU>57</SU>
                        <FTREF/>
                         Dorian (2019) 
                        <E T="51">58 59</E>
                        <FTREF/>
                         and Tropical Storm Barry (2019).
                        <E T="51">60 61</E>
                        <FTREF/>
                         Generally, EPA extended the time frame for notification and allowed spills to be managed based on the as-found concentration for spills directly caused by the emergency situation.
                    </P>
                    <FTNT>
                        <P>
                            <SU>53</SU>
                             Letter from Jesse Baskerville to Mary Davis, Nov 9, 2005. Guidance for Addressing Spills from Electrical Equipment [damaged by Hurricane Rita or Katrina].
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>54</SU>
                             Correspondence from James Sales, EPA to Mary Davis. Aug 29, 2017. PCB Disaster Debris Cleanup Guidance.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>55</SU>
                             Memo from Alan Farmer to Barnes Johnson, Sept 8, 2017. EPA Region 4 Issuance of Disaster Waste Guidance.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>56</SU>
                             Memo from Susan Hansen to Barnes Johnson. Sept 13, 2018. EPA Region 4 Issuance of Disaster Waste Guidance.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>57</SU>
                             Memo from Susan Hansen to Barnes Johnson. Oct 10, 2018. EPA Region 4 Issuance of Disaster Waste Guidance.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>58</SU>
                             Memo from John Armstead to Barnes Johnson. Sept 4, 2019. EPA Region 3 Issuance of Disaster Waste Guidance.
                        </P>
                        <P>
                            <SU>59</SU>
                             Memo from Carol J. Monell to Barnes Johnson. Sept 3, 2019. EPA Region 4 Issuance of Disaster Waste Guidance.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>60</SU>
                             Memo from Ronnie Crossland to Barnes Johnson. July 11, 2019. EPA Region 6 Issuance of Disaster Waste Guidance.
                        </P>
                        <P>
                            <SU>61</SU>
                             Memo from Carol J. Monell to Barnes Johnson. July 18, 2019. EPA Region 4 Issuance of Disaster Waste Guidance.
                        </P>
                    </FTNT>
                    <P>EPA recognizes that issuing the guidance on a case-by-case basis can create some inefficiencies. First, since disasters can develop without forewarning, they can put pressure on EPA to develop the guidance quickly so that it may be distributed to the regulated community in time for facilities to use it. Also, the fast-paced nature of the response to such events means that entities that could use the guidance may not become aware that it was issued in time to use it. Finally, due to uncertainty regarding whether a guidance document will be issued, it is often challenging for regulated facilities to include the flexibilities offered in the EPA guidance into their disaster preparation protocols. EPA received comments from industry requesting a more standardized set of flexibilities, citing several of these reasons.</P>
                    <HD SOURCE="HD3">What is EPA proposing on this issue?</HD>
                    <P>EPA proposes two independent changes to make the PCB regulatory requirements more practical during emergency situations. First, EPA is proposing that two additional flexibilities for spills caused by emergency situations be added to the PCB Spill Cleanup Policy in Subpart G. Second, EPA is proposing to create an option to apply for a waiver from various cleanup, storage, and disposal requirements for releases caused by emergency situations, when meeting those requirements as stated in the regulations would be impracticable. EPA is looking for comment on both changes and may finalize either option or both options. EPA is also proposing to establish a definition of an “emergency situation” to clarify the applicability of the proposed changes.</P>
                    <HD SOURCE="HD3">a. Definition of “Emergency Situation”</HD>
                    <P>EPA proposes to add identical definitions of “emergency situation” to §§ 761.3 and 761.123. Specifically, EPA proposes to define an emergency situation as adverse conditions caused by manmade or natural incidents that threaten lives, property, or public health and safety and require prompt responsive action from the local, state, tribal, territorial, or federal government. Furthermore, these adverse conditions must result in either: (1) A declaration by either the President of the United States or governor of the affected state of a natural disaster or emergency; or, (2) an incident funded under the Federal Emergency Management Agency (FEMA) via a Stafford Act disaster declaration or emergency declaration. Examples of emergency situations may include civil emergencies or adverse natural conditions, such as hurricanes, earthquakes, or tornados. EPA is proposing this definition because it is sufficiently broad to capture a wide range of emergencies that would be likely to significantly impact the cleanup and disposal of PCB waste. At the same time, the definition is contingent upon a declaration of emergency from an established authority, which are generally made in an objective and timely manner. EPA is seeking comment on the proposed definition of an “emergency situation.” In particular, EPA would like to know if there is a corresponding tribal authority able to declare a state of emergency that should be included in the definition.</P>
                    <HD SOURCE="HD3">b. Additional Flexibilities Under the Spill Cleanup Policy for Spills Caused by Emergency Situations</HD>
                    <P>In this rulemaking, EPA proposes to expand the existing flexibilities in the Spill Cleanup Policy in Subpart G to be available in all emergency situations, rather than on a case-by-case basis. First, EPA proposes to allow the responsible party to clean up a spill caused by an emergency situation (which would be defined in 40 CFR 761.123, as discussed above) based on the as-found PCB concentration when the source concentration cannot readily be determined, as is common in emergency situations. Specifically, EPA is proposing to allow responsible parties to use the as-found concentration when determining whether the spill can be managed under §§ 761.125(b) or 761.125(c) for actions taken directly in response to spills caused by emergency situations. To this end, EPA proposes to add “except where authorized in § 761.120(c)” to the definition of “spill” to accommodate the proposed flexibility to manage waste at the as-found concentration. EPA believes these proposed changes would avoid delays associated with searches for the source of the spill during or immediately following an emergency situation, where the search is likely to be time-consuming and unsuccessful, thereby expediting cleanups and reducing any potential exposure more quickly.</P>
                    <P>
                        Secondly, EPA proposes to add flexibility to the timeframe for completing notification under the Spill Cleanup Policy. Generally, the Spill Cleanup Policy specifies that notification be made within 24 hours after the responsible party was notified or became aware of the spill, see § 761.125(a)(1). Under EPA's proposed changes, when the Policy is used for cleanup activities undertaken directly in response to spills caused by emergency situations, as would be defined in § 761.123, the policy would extend the timeframe for reporting to seven days after the adverse conditions that prevented communication have ended. Often in emergencies, communication networks are stretched thin and responsible parties may need extra time 
                        <PRTPAGE P="58743"/>
                        to notify the required entities.
                        <SU>62</SU>
                        <FTREF/>
                         This proposed change would only pertain to reporting required under § 761.125(a)(1) that is directly impacted by the adverse conditions. There is no need to provide for flexibility as to the timeframe for cleanup completion in emergency situations because the Spill Cleanup Policy already incorporates this flexibility under §§ 761.125(b)(2) and 761.125(c)(1)(vi).
                    </P>
                    <FTNT>
                        <P>
                            <SU>62</SU>
                             Planning for Natural Disaster Debris. EPA. April 2019. p. 66 
                            <E T="03">https://www.epa.gov/sites/production/files/2019-05/documents/final_pndd_guidance_0.pdf.</E>
                        </P>
                    </FTNT>
                    <P>EPA believes that the proposed flexibilities would not present an unreasonable risk of injury to health or the environment under the defined emergency situations but rather would result in a net benefit in protection of health and the environment, given that they allow those conducting the spill response to assess and dispose of waste more quickly, and prioritize time-sensitive remedial actions.</P>
                    <HD SOURCE="HD3">c. Waiver From Various Sampling, Extraction, Analysis, Cleanup, Storage, and Disposal Requirements in Emergency Situations</HD>
                    <P>EPA proposes to create an option to apply for a waiver from various PCB waste management requirements when necessitated by emergency situations. Responsible parties would be able to request a waiver from the provisions of §§ 761.60, 761.61, 761.62, and 761.65, which provide requirements for sampling, extraction, analysis, cleanup, storage, and disposal of all types of regulated PCB wastes.</P>
                    <P>
                        Cleanup and disposal activities often cannot be initiated promptly in emergency situations such as hurricanes, due to necessary emergency response actions taking place. EPA recognizes that spills caused by an emergency situation may not be discovered or be able to be cleaned up until after the emergency ends or until after the initial emergency response. EPA regularly negotiates and implements special arrangements during emergency situations on a case-by-case basis, which can delay implementation of remedial actions. EPA is proposing to modify the PCB regulations to allow the person managing the cleanup and/or disposal of PCB waste caused by an emergency situation to request waivers from applicable PCB sampling, extraction, analysis, cleanup, storage, disposal and other regulatory requirements when there is an emergency situation and the existing regulatory requirements (
                        <E T="03">e.g.,</E>
                         timeframes, sampling protocols) are impracticable due to the nature of the emergency situation. Due to the varied nature of the emergency situations that would be covered by this waiver option, EPA is proposing to allow requests that would modify specific requirements from a broad swath of the PCB cleanup and disposal regulations. Requests would need to be submitted to EPA within seven days of discovery of the PCB waste. Under the proposed waiver provisions, EPA would individually evaluate each request and would only approve those that provide sufficient information to justify modifying select requirements upon a determination that the modifications would not present an unreasonable risk of injury to health or the environment. Successful waiver requests must identify the specific requirements to be waived or modified, the adverse conditions caused by the emergency situation, why fulfillment of those specific requirements would be impracticable and the proposed method of managing the PCB waste in lieu of the waived requirements. EPA expects most waivers to be temporary with a specified end-date, requiring the recipient of the waiver to meet full regulatory requirements after the emergency conditions no longer impede the ability to comply. For example, the waiver recipient can perform immediate cleanup without fully verifying that cleanup levels have been met; however, once the emergency conditions are over, the recipient would need to determine whether cleanup levels have been met, and perform additional cleanup, if needed. Similarly, EPA intends that the disposal options for a given waste will rarely, if ever, be modified under the waiver option, as the final disposition of the waste is, by nature, permanent and would therefore outlast the adverse conditions. EPA is including disposal requirements in the scope of the waiver option to accommodate rare or extenuating circumstances, for example, the disposal of mixed or partially characterized waste streams, where waste stream segregation or full characterization is not practicable. Therefore, EPA anticipates that impacts to communities near sites where this provision is exercised would be limited in the short term and as protective in the long term. See proposed § 761.66.
                    </P>
                    <P>The proposed option allows a person to request a waiver by sending site information and a sampling, cleanup, and/or disposal plan that describes the requested deviation from the generally applicable regulatory requirements to the relevant EPA Regional Administrator. The EPA Regional Administrator would review the request and determine whether compliance with the regulatory requirements from which a waiver is sought is impracticable and whether the action approved under the waiver would not pose an unreasonable risk of injury to health or the environment. The EPA Regional Administrator could grant or deny such a waiver request or may grant the request with changes or conditions beyond those described in the waiver request, such as design standards, marking, or time limits, and would communicate those conditions to the requestor. EPA is considering posting approved waivers publicly on the EPA website to promote transparency and awareness of the use of the waiver option in the local community. EPA is requesting comment on the proposed waiver option, particularly comments on ensuring that the waiver option would be used effectively in real-world emergency situations without presenting an unreasonable risk of injury to health or the environment. EPA is also requesting comment on posting approved waivers online, from both the public's and the requestor's perspectives.</P>
                    <P>Independent of EPA's proposed additions above, EPA notes that § 761.61 currently “does not prohibit any person from implementing temporary emergency measures to prevent, treat, or contain further releases or mitigate migration to the environment of PCBs or PCB remediation waste.” This means that immediate measures may be taken to contain PCBs during an emergency situation prior to receiving approval from the EPA Regional Administrator as described in § 761.66(b). Such examples might include excavating visibly contaminated soil near storm drains or removing and storing leaking electrical equipment that contains PCB oil before the remaining oil is released to the environment.</P>
                    <HD SOURCE="HD2">G. Harmonize General Disposal Requirements for PCB Remediation Waste</HD>
                    <HD SOURCE="HD3">Background on This Issue</HD>
                    <P>
                        In the 1998 PCB Megarule (63 FR 35384), EPA promulgated both the definition of PCB remediation waste in § 761.3 and a guide to the cleanup and disposal obligations for PCB remediation waste in § 761.50(b)(3). At the time of the 1998 Megarule, § 761.50(b)(3) failed to account for the fact that disposal of PCBs &lt; 500 ppm was not regulated between April 18, 1978, (the effective date of the Disposal and Marking Rule, which set the 500 ppm threshold) and July 2, 1979 (the effective date of the PCB Ban Rule, 
                        <PRTPAGE P="58744"/>
                        which replaced the 500 ppm level with 50 ppm). A technical amendment to correct this discrepancy was issued in 1999 (64 FR 33755). The preamble text addressed changes made to § 761.50(b)(3)(i), which was amended accordingly. Section 761.50(b)(3)(ii) was also amended, presumably to correct the same discrepancy for the time between April 18, 1978 and July 2, 1979. However, the phrase “at as-found concentrations ≥50 ppm” was added to § 761.50(b)(3)(ii) unnecessarily. This addition was apparently an error; there is no justification in the preamble for the change, and it could be read to cut against the apparent intent to better align § 761.50(b)(3) with the definition of PCB remediation waste and the general direction in § 761.50(b)(3) that PCB remediation waste “is regulated for cleanup and disposal in accordance with § 761.61.”
                    </P>
                    <P>
                        In keeping with the regulatory text overall, preamble and guidance statements, and interactions with the regulated community, EPA does not interpret the “as found” language in § 761.50(b)(3)(ii) as limiting the cleanup and disposal obligations for PCB remediation waste created by releases that occurred on or after the dates referenced in that clause, where the as-found PCB concentration is &lt;50 ppm. Rather, EPA maintains that all materials that fit the definition of PCB remediation waste in § 761.3—including materials which are currently at any volume or concentration where the original source was ≥500 ppm PCBs beginning on April 18, 1978, or ≥50 ppm PCBs beginning on July 2, 1979—are regulated for cleanup and disposal under § 761.61. The introductory language to § 761.50(b)(3) provides, without exception, that “PCB remediation waste . . . is regulated for cleanup and disposal in accordance with § 761.61.” EPA has published guidance affirming that PCB remediation waste, even if &lt;50 ppm, is regulated under § 761.61.
                        <SU>63</SU>
                        <FTREF/>
                         EPA has also issued numerous risk-based disposal approvals in the past five years that apply only to &lt;50 ppm PCB remediation waste.
                        <SU>64</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>63</SU>
                             PCB Q&amp;A Manual. June 2014. Pg. 49 Q.3 
                            <E T="03">https://www.epa.gov/sites/production/files/2015-08/documents/qacombined.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>64</SU>
                             Nationwide Risk-based PCB Remediation Waste Disposal Approvals. 
                            <E T="03">https://www.epa.gov/pcbs/nationwide-risk-based-pcb-remediation-waste-disposal-approvals.</E>
                        </P>
                    </FTNT>
                    <P>
                        In EPA's view, the function of § 761.50(b)(3)(ii) is to clarify that PCB remediation waste created by releases that occurred on or after the dates referenced in that clause can be managed either in accordance with the PCB Spill Cleanup Policy if it meets the criteria established in the Policy, as provided in § 761.50(b)(3)(ii)(A); or in accordance with § 761.61, as provided in § 761.50(b)(3)(ii)(B) and the introductory text to § 761.50(b)(3). This intention is reflected in the 1998 Megarule preamble, which states: “With regard to sites containing PCB remediation wastes generated on or after April 18, 1978, owners or operators of those sites now have two choices: They may clean up the wastes in accordance with the new § 761.61, or, if applicable, they may cleanup the wastes in accordance with EPA's Spill Cleanup Policy, part 761, subpart G.”.
                        <SU>65</SU>
                        <FTREF/>
                         (In contrast, the older PCB remediation waste addressed under § 761.50(b)(3)(i) is not eligible for management under the Spill Cleanup Policy.) Thus, as EPA interprets § 761.50(b)(3)(ii), the effect of adding the “as-found” limitation to the provision was to suggest that PCB remediation waste created by releases that occurred on or after the dates referenced in that clause, where the as-found PCB concentration is &lt; 50 ppm, is not eligible for management under the Spill Cleanup Policy, but only under § 761.61 as provided in the introductory text. EPA did not intend to so limit the Policy, which applies to the cleanup of certain spills resulting from the release of materials containing PCBs ≥50 ppm but is not dependent on the as-found concentrations of the materials contaminated by such spills.
                    </P>
                    <FTNT>
                        <P>
                            <SU>65</SU>
                             Megarule Preamble 63 FR 35402.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">What is EPA proposing on this issue?</HD>
                    <P>EPA proposes to change the language in § 761.50(b)(3)(ii) by removing the phrase “at as found concentrations ≥50 ppm.” This proposed change would avoid potential confusion over the meaning of § 761.50(b)(3)(ii) and make clear, consistent with the regulatory text and guidance, that all PCB remediation waste is subject to § 761.61, and that all qualifying PCB remediation waste can be managed under the Spill Cleanup Policy regardless of its as-found concentration. Since this regulatory change is in line with current EPA policy, guidance, and practice, EPA estimates no net economic impacts from this change. EPA is requesting comment on this proposed change. See proposed § 761.50(b)(3)(ii).</P>
                    <HD SOURCE="HD2">H. Make Changes To Improve Regulatory Implementation</HD>
                    <P>EPA proposes several supplemental amendments to improve implementation of existing requirements, clarify regulatory ambiguity, and correct technical errors in the PCB regulations. EPA requests comment on each proposed change listed below.</P>
                    <HD SOURCE="HD3">Medium Density Plastics as Non-Porous Surfaces</HD>
                    <P>
                        The definition of “non-porous surface” in § 761.3 includes several examples, including high-density plastics. EPA is proposing to modify this definition to include medium-density plastics as an example of a non-porous surface. In December 2018, EPA issued an interpretive letter to the American Gas Association which found that medium- and high-density polyethylene used in natural gas distribution piping meet the definition of a “non-porous surface” under § 761.3.
                        <SU>66</SU>
                        <FTREF/>
                         EPA found that the study titled, 
                        <E T="03">Assessment of Polychlorinated Biphenyls (PCBs) in Polyethylene (PE) Gas Distribution Piping,</E>
                         conducted by NYSEARCH and National Grid, demonstrated that the amount of PCB absorption into medium- and high-density polyethylene pipe was minimal, and penetration of PCBs beyond the immediate surface was limited.
                        <SU>67</SU>
                        <FTREF/>
                         EPA is taking comment on whether the relevant properties of medium-density polyethylene are representative of medium-density plastics generally. See proposed § 761.3.
                    </P>
                    <FTNT>
                        <P>
                            <SU>66</SU>
                             Letter from Barnes Johnson to Pamela Lacey. Dec 14, 2018. 
                            <E T="03">https://www.epa.gov/pcbs/epas-response-letter-aga-regarding-mdpe-and-hdpe-non-porous-surface.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>67</SU>
                             JANA on behalf of NYSEARCH NGA. Oct 19, 2018. Assessment of Polychlorinated Biphenyls (PCBs) in Polyethylene (PE) Gas Distribution Piping. Revision 2.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Temporary Storage in Containers at the Site of Generation</HD>
                    <P>The PCB regulations permit the storage of bulk PCB remediation waste in piles at the site of generation for up to 180 days under § 761.65(c)(9). In response to requests from generators, EPA is proposing to allow the use of non-leaking, covered containers under the same provision. Waste stored in containers would have to meet all of the same criteria as waste stored in piles, and thus would not incur additional risk. See proposed § 761.65(c)(9).</P>
                    <HD SOURCE="HD3">Language Modifications for Financial Assurance Instruments</HD>
                    <P>
                        The PCB regulations at § 761.65(g) currently require commercial storers of PCB waste to establish financial assurance for closure of PCB storage facilities by choosing from financial assurance mechanisms in the RCRA regulations under 40 CFR part 264. Part 264 includes prescribed language that must be included in each type of 
                        <PRTPAGE P="58745"/>
                        financial instrument. Some variation from the RCRA instrument wording may be necessary for the purposes of effectuating the financial assurance requirements under TSCA. EPA is proposing to allow the Regional Administrator (RA) the flexibility to modify the language required in financial assurance instruments for the purposes of implementation under TSCA. These proposed changes would allow the RA to request modification to the terms of those instruments to account for the fact that they are being used to fulfill a financial assurance obligation under TSCA; for example, changes to the instrument wording so that references to RCRA may be replaced with references to TSCA, or changes to the instruments to better comport with the legal authorities under, and applicable to, TSCA. The proposed changes must be made throughout § 761.65(g), once for each of the financial instruments. See proposed §§ 761.65(g)(1), 761.65(g)(1)(iv), 761.65(g)(2), 761.65(g)(3)(i), 761.65(g)(4)(i), 761.65(g)(5), 761.65(g)(6), and 761.65(g)(7).
                    </P>
                    <HD SOURCE="HD3">Remove Manifest Tracking Numbers From Annual Reports</HD>
                    <P>EPA proposes to remove the provision at § 761.180(b)(3)(ii) requiring owners or operators of PCB disposal facilities or commercial storage facilities to record, as part of their logs, lists of manifest tracking numbers (MTNs) of signed PCB manifests either received by or generated at the facility for purposes of annual reporting. As of June 30, 2018, receiving facilities must submit final, signed manifests to EPA's hazardous waste electronic manifest (e-Manifest) system. Since PCB manifests can now be obtained from the e-Manifest system, EPA no longer needs this information to be submitted as part of the annual reporting requirement. In place of the aforementioned requirement, EPA would mark § 761.180(b)(3)(ii) as “[Reserved].” See proposed § 761.180(b)(3)(ii).</P>
                    <HD SOURCE="HD3">Mandatory Form for Annual Reports</HD>
                    <P>EPA proposes to modify how the annual report information is submitted to the Agency. While § 761.180(b)(3) describes the information EPA requires in the annual report, it does not specify a format. This lack of clarity has led to confusion on the part of both EPA and the regulated entities. EPA is proposing to require a standard form be used for the submission of annual reports. Use of the form would standardize the format and improve the data quality, allowing EPA to process the reports in less time. The form will also reduce reporting burden on some members of the regulated community who submit much more than the required information, such as facilities that send copies of every manifest instead of every manifest tracking number. Furthermore, the instructions for the form would clarify EPA's expectations; for example, facilities should report “zero” in all categories for which they did not manage PCB waste in that calendar year. At present, many facilities omit categories, making it unclear as to whether this is an oversight or a determination that the categories do not pertain to them.</P>
                    <HD SOURCE="HD3">PCB Waste Categories on the Manifest</HD>
                    <P>
                        EPA proposes to revise the categories of PCB waste specified by the generator on the manifest to match the categories of PCB waste specified by the commercial storer or disposer in the annual document log and annual report. Harmonizing these PCB waste categories would streamline recordkeeping for commercial storers and disposers, while imposing negligible burden on the generators. Currently, § 761.207(a) requires PCB waste to be listed on the manifest as either “bulk PCBs,” “PCB Article Container or PCB Container,” or “PCB Article not in a PCB Container or PCB Article Container.” EPA is proposing to modify § 761.207(a) to list the five categories from § 761.180(b)(3)(iii) through (vi). If finalized, the categories in § 761.207(a) would be “bulk PCBs,” “PCB Transformers,” “PCB Large High or Low Voltage Capacitors,” “PCB Article Containers,” and “PCB Containers.” 
                        <SU>68</SU>
                        <FTREF/>
                         The requirements for supporting data (unique identification number, weight in kilograms, date removed from service) would remain the same. EPA is also proposing to remove references to instructions in the Appendix of Part 262 because the instructions were recently removed from it and are available on EPA's website.
                        <SU>69</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>68</SU>
                             While the text in § 761.180(b)(3)(iii) through (vi) is of the format “PCB waste in PCB Containers,” due to limited space in Box 14 of the manifest form, EPA chose to simplify the language to “PCB Containers” or similar.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>69</SU>
                             
                            <E T="03">https://www.epa.gov/hwgenerators/uniform-hazardous-waste-manifest-instructions-sample-form-and-continuation-sheet.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Define “As-Found Concentration”</HD>
                    <P>EPA proposes to add a definition of “as-found concentration” to § 761.3. “As-found concentration” is used in the PCB regulations particularly in reference to PCB remediation waste (§§ 761.50(b) and 761.61). The proposed language clarifies that the as-found concentration must be measured from samples collected in-situ, unless otherwise specifically provided. Existing accumulations, as described in § 761.340(a) would be one such exception. Often, ex-situ sampling reduces the concentration of PCBs in environmental media through dilution.</P>
                    <P>
                        The proposed definition would provide that “As-found concentration means the concentration measured in samples of environmental media or material collected in-situ (
                        <E T="03">i.e.</E>
                         prior to being moved or disturbed for cleanup and/or disposal), unless otherwise specifically provided. For example, soils must not be disturbed, nor may they be diluted (
                        <E T="03">e.g.,</E>
                         excavated, placed on a pile, and sampled after such placement) before characterization sampling is conducted. Sampling media in piles and existing accumulations would be considered “as-found” if the media were already in piles when the site was first visited by the responsible party, such as during the redevelopment of abandoned properties with historic PCB contamination. The as-found concentration is distinct from the source concentration, which is the concentration of the PCBs in the material that was originally spilled, released, or otherwise disposed of at the site.”
                    </P>
                    <HD SOURCE="HD3">Clarify § 761.61(a) Cleanups Must Comply With All Applicable Requirements</HD>
                    <P>EPA proposes to clarify that responsible parties must ensure that notifications submitted under § 761.61(a) comply with all requirements of § 761.61(a)(3)(i) in order to proceed without EPA approval 30 days after submission to EPA. EPA is also proposing to add language clarifying that the subsequent cleanup and disposal must comply with all applicable requirements in § 761.61(a)(4) through (9).</P>
                    <P>The regulations at § 761.61(a) establish a 30-day time frame for EPA to review and react to self-implementing cleanup notifications. If the Agency does not respond within 30 days of receiving the notification, the person may proceed with cleanup and disposal in accordance with the information in the submitted notification. This provision, as currently written, equates EPA's silence over the 30-day period with a determination by EPA that the notification is complete and accurate. EPA believes that the responsible party should be responsible for verifying completeness and accuracy of the notification.</P>
                    <P>
                        EPA is proposing to remove the section of text that states the responsible party may assume that the notification 
                        <PRTPAGE P="58746"/>
                        is complete and acceptable if the Agency does not respond within 30 days. The responsible party may still proceed with the cleanup if the Agency does not respond within 30 days. However, if upon review EPA determines that the notification does not contain all of the information required by § 761.61(a)(3)(i), sufficient to ensure compliance with § 761.61(a)(4) through (9) at the site, the Agency may require the submission of additional information. Furthermore, regardless of the content of the notification, the proposed language states that the cleanup and disposal must meet all requirements of § 761.61(a)(4) through (9). If the applicant has reason to believe their implementation of § 761.61(a) may not satisfy the regulatory requirements, it would be in their best interest, from a compliance assurance perspective, to contact the appropriate EPA Regional PCB Coordinator prior to the end of the 30-day period (or earlier) or at least prior to commencing the cleanup and disposal activities. See the EPA PCB website for a list of the EPA Regional PCB Coordinators 
                        <E T="03">www.epa.gov/pcbs/program-contacts.</E>
                         See proposed § 761.61(a)(3)(ii).
                    </P>
                    <HD SOURCE="HD3">Harmonize PCB Concentration Language Regarding Cap Material</HD>
                    <P>
                        EPA proposes to correct a remediation waste cap requirement to provide consistency with the rest of the PCB regulations. Currently, § 761.61(a)(7) requires that “a cap shall not be contaminated at a level ≥1 ppm PCB per Aroclor
                        <SU>TM</SU>
                         (or equivalent) or per congener.” EPA is proposing to delete “per Aroclor
                        <SU>TM</SU>
                         (or equivalent) or per congener” to make this requirement consistent with the rest of the PCB regulations. A PCB congener is a single version of the PCB molecule, with a number of chlorine atoms attached to the benzene rings in different configurations. Theoretically, there are 209 PCB congeners possible.
                        <SU>70</SU>
                        <FTREF/>
                         Aroclors are mixtures of PCB congeners that were manufactured between 1929 and 1979; there are sixteen known Aroclors.
                        <SU>71</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>70</SU>
                             
                            <E T="03">https://www.epa.gov/pcbs/table-polychlorinated-biphenyl-pcb-congeners.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>71</SU>
                             
                            <E T="03">https://www.epa.gov/pcbs/table-aroclors.</E>
                        </P>
                    </FTNT>
                    <P>
                        Other than this paragraph, the regulations only specify requirements or restrictions based on PCB concentrations, rather than PCB congener concentrations or PCB Aroclor concentrations. The PCB regulations at § 761.1(b)(2) state “Unless otherwise provided, PCBs are quantified based on the formulation of PCBs present in the material analyzed,” which means that when PCBs are present as Aroclors, 
                        <E T="03">e.g.,</E>
                         in PCB transformer oil, they should be measured and reported as Aroclors. When PCBs are present as congeners, 
                        <E T="03">e.g.,</E>
                         in weathered environmental samples, they should be measured and reported as congeners. Furthermore, there is no technical or risk-based reason why PCB remediation waste cap requirements should differ from other sections of the PCB regulations. As a result, the newly proposed language simply requires that “a cap shall not be contaminated at a level ≥1 ppm PCB.” This designation is consistent with how PCB limits are described in the rest of the TSCA PCB regulations. See proposed § 761.61(a)(7).
                    </P>
                    <HD SOURCE="HD3">Clarify Applicability of Deed Restrictions</HD>
                    <P>
                        EPA proposes to clarify the requirements for deed restrictions associated with PCB remediation waste being left on-site under a self-implementing cleanup and disposal activity (§ 761.61(a)). The self-implementing cleanup and disposal option for PCB remediation waste provides for varying cleanup levels based on the occupancy level and the presence of a fence or cap. When cleanup levels are based upon low occupancy of the cleanup area or the existence of a fence or cap (either in high or low occupancy areas), deed restrictions are required (see § 761.61(a)(8)). EPA intends for the December 2012 Institutional Controls document to provide guidance on how to effectively plan, implement, maintain, and enforce deed restrictions required under § 761.61(a)(8).
                        <SU>72</SU>
                        <FTREF/>
                         EPA's 2005 PCB Site Revitalization Guidance confirms that § 761.61(a)(8) requires a deed restriction for all cleanups requiring caps or fences, and all cleanups based on low-occupancy uses.
                        <SU>73</SU>
                        <FTREF/>
                         However, portions of the regulatory text could suggest that the deed restriction must reference low-occupancy status 
                        <E T="03">and</E>
                         the existence of a cap or fence in every case, even though some sites with low occupancy cleanups will not have caps or fences, and some sites with caps or fences will not be low-occupancy. In particular, the text of § 761.61(a)(8)(i)(A) could suggest that all of the elements identified in § 761.61(a)(8)(i)(A)(1) through (3) (
                        <E T="03">i.e.,</E>
                         low-occupancy and caps or fences) will be present at sites subject to the deed restriction, whereas EPA plainly intended the deed requirement to apply to all sites cleaned up to low-occupancy levels, and/or requiring caps or fences. To remedy any potential for confusion, EPA is proposing several minor edits to § 761.61(a)(8) to clarify that deed restrictions apply to any area with a cap, a fence, or a low occupancy designation.
                    </P>
                    <FTNT>
                        <P>
                            <SU>72</SU>
                             Institutional Controls: A Guide to Planning, Implementing, Maintaining, and Enforcing Institutional Controls at Contaminated Sites. December 2012. 
                            <E T="03">https://www.epa.gov/sites/production/files/documents/final_pime_guidance_december_2012.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>73</SU>
                             Polychlorinated Biphenyl (PCB) Site Revitalization Guidance Under the Toxic Substances Control Act (TSCA). November 2005. Page 13. 
                            <E T="03">https://www.epa.gov/sites/production/files/2015-08/documents/pcb-guid3-06.pdf.</E>
                        </P>
                    </FTNT>
                    <P>In addition, EPA proposes to clarify in § 761.61(a)(8)(i)(A) that the deed restriction should designate the portion of a property that is subject to the deed restriction, when applicable. The deed restriction should reference the location of the cap, fence, or low occupancy portion in a format that makes sense for the site, for example, latitude/longitude coordinates, street address, or annotated areal image.</P>
                    <HD SOURCE="HD3">Include Alternate Extraction and Analysis Under § 761.61(c)—PCB Remediation Waste</HD>
                    <P>EPA proposes to clarify that the risk-based approval under § 761.61(c) can be used to modify or replace the extraction or analysis methods required for PCB remediation waste in lieu of a Subpart Q comparison study. EPA's current practice is to allow responsible parties to request to modify or replace an extraction or analysis method, as they are considered part of the sampling requirements. The proposed change would simply clarify that responsible parties have this option, by adding “extraction, analysis” to the list of modifiable requirements under a § 761.61(c) risk-based approval.</P>
                    <HD SOURCE="HD3">Include Alternate Extraction and Analysis Under § 761.62(c)—PCB Bulk Product Waste</HD>
                    <P>EPA proposes to clarify that the risk-based approval under § 761.62(c) can be used to modify or replace the extraction or analysis methods required for PCB bulk product waste in lieu of a Subpart Q comparison study. EPA's current practice is to allow responsible parties to request to modify or replace an extraction or analysis method, as they are considered part of the sampling requirements. The proposed change would simply clarify that responsible parties have this option, by adding “extraction, analysis” to the list of modifiable requirements under a § 761.62(c) risk-based approval.</P>
                    <HD SOURCE="HD3">Include Alternate Extraction and Analysis Under § 761.79(h)—Decontaminated Material</HD>
                    <P>
                        EPA proposes to clarify that an approval under § 761.79(h) can be used to modify or replace the extraction or 
                        <PRTPAGE P="58747"/>
                        analysis methods required for decontaminated PCB waste in lieu of a Subpart Q comparison study. EPA's current practice is to allow responsible parties to request to modify or replace an extraction or analysis method, as they are considered part of the sampling procedure. The proposed change would simply clarify that responsible parties have this option, by adding “extraction, analysis” to the list of modifiable requirements under a § 761.79(h) approval.
                    </P>
                    <HD SOURCE="HD3">Clarify Sampling Procedure for Non-Porous Surfaces</HD>
                    <P>
                        EPA proposes to correct an inconsistency in the site characterization requirements for non-porous surfaces conducted pursuant to the self-implementing cleanup option for PCB remediation waste (§ 761.61(a)). This self-implementing cleanup and disposal option states that site characterization of non-porous surfaces may be conducted using procedures included in Subpart N. The method found in Subpart N for sampling non-porous surfaces (§ 761.267) specifies that the sampling area shall be divided into “square portions approximately 2 meters on each side” and “[f]ollow[ing] the procedures in § 761.302(a).” However, § 761.302(a), which is the section of the regulations pertaining to post-cleanup sampling of non-porous surfaces, specifies dividing the surface into 1 meter square portions instead of 2 meters. EPA is proposing to amend § 761.267 by adding the following italicized language to this provision, “Follow the procedures in § 761.302(a), 
                        <E T="03">with the exception of the sampling grid size,</E>
                        ” to correct this inconsistency. This change reflects the way in which the EPA has already been addressing the inconsistency. See proposed § 761.267(a).
                    </P>
                    <HD SOURCE="HD3">Add Unit to Concentration in § 761.1(b)(3)</HD>
                    <P>
                        Currently, § 761.1(b)(3) lists a concentration with only partial units of reference, “PCB concentrations of &gt;10/100 cm
                        <SU>2</SU>
                        ,” which is meaningless, as written. It is clear from context that the text should read “PCB concentrations of ≥10 μg/100 cm
                        <SU>2</SU>
                        ,” which is how the referenced concentration otherwise appears throughout the PCB regulations, for example in § 761.79(b). Thus, EPA is proposing to modify the § 761.1(b)(3) text to read “PCB concentrations of ≥10 μg/100 cm
                        <SU>2</SU>
                        .” EPA is also proposing to harmonize the “greater/less than” and “greater/less than or equal to” symbols in this section. See proposed § 761.1(b)(3).
                    </P>
                    <HD SOURCE="HD3">Update ASTM Methods</HD>
                    <P>The regulations at § 761.19 incorporate by reference several ASTM test method standards that have since been updated. These ASTM standards reflect the current consensus of ASTM members. EPA proposes to make the following changes:</P>
                    <P>
                        ASTM D93-09, Standard Test Methods for Flash Point by Pensky-Martens Closed Tester, was approved by ASTM in 2009 and added to the PCB regulations in 2012 at §§ 761.71(b)(2)(vi) and 761.75(b)(8)(iii).
                        <SU>74</SU>
                        <FTREF/>
                         EPA is proposing to add as an alternative ASTM D8175-18, Test Method for Finite Flash Point Determination of Liquid Wastes by Pensky-Martens Closed Cup Tester.
                    </P>
                    <FTNT>
                        <P>
                            <SU>74</SU>
                             77 FR 2463, Jan. 18, 2012.
                        </P>
                    </FTNT>
                    <P>
                        ASTM D3278-89, Standard Test Methods for Flash Point of Liquids by Setaflash Closed-Cup Apparatus, was approved by ASTM in 1989 and added to the PCB regulations in 1992 at § 761.75(b)(8)(iii).
                        <SU>75</SU>
                        <FTREF/>
                         EPA is proposing to replace it with the updated version, ASTM D3278-96 (Reapproved 2011), Standard Test Methods for Flash Point of Liquids by Small Scale Closed-Cup Apparatus, and add ASTM D8174-18, Test Method for Finite Flash Point Determination of Liquid Wastes by Small Scale Closed Cup Tester at §§ 761.71(b)(2)(vi) and 761.75(b)(8)(iii).
                    </P>
                    <FTNT>
                        <P>
                            <SU>75</SU>
                             57 FR 13323, Apr. 16, 1992.
                        </P>
                    </FTNT>
                    <P>
                        EPA is proposing to remove ASTM D2784-89, Standard Test Method for Sulfur in Liquified Petroleum Gases (Oxy-hydrogen Burner or Lamp) from § 761.19 and § 71(a)(2)(vi). This test method was withdrawn in June 2016 because it is archaic and not used in the industry.
                        <SU>76</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>76</SU>
                             
                            <E T="03">https://compass.astm.org/Standards/WITHDRAWN/D2784.htm.</E>
                        </P>
                    </FTNT>
                    <P>
                        EPA is proposing to replace ASTM D3178-84, Standard Test Methods for Carbon and Hydrogen in the Analysis Sample of Coke and Coal, with D5373-16, Standard Test Methods for Determination of Carbon, Hydrogen and Nitrogen in Analysis Samples of Coal and Carbon in Analysis Samples of Coal and Coke, in §§ 761.19 and 761.71(a)(2)(vi). ASTM D3178-84 was replaced in June 2007 because there was no reproducibility statement for D3178.
                        <SU>77</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>77</SU>
                             
                            <E T="03">https://compass.astm.org/Standards/WITHDRAWN/D3178.htm.</E>
                        </P>
                    </FTNT>
                    <P>EPA is proposing to update ASTM Standard D-4059, Standard Test Method for Analysis of Polychlorinated Biphenyls in Insulating Liquids by Gas Chromatography, with ASTM D4059-00 (Reapproved 2018), Standard Test Methods for Analysis of Polychlorinated Biphenyls in Insulating Liquids by Gas Chromatography, in §§ 761.19 and 761.60(g)(iii).</P>
                    <P>EPA is proposing to replace ASTM D482-87, Standard Test Method for Ash from Petroleum Products, with ASTM D482-13, Standard Test Method for Ash from Petroleum Products, in § 761.71(a)(2)(vi). EPA is also proposing to replace ASTM D3278-89, Standard Test Methods for Flash Point of Liquids by Setaflash Closed-Cup Apparatus, with ASTM D3278-96, Standard Test Methods for Flash Point of Liquids by Small Scale Closed-Cup Apparatus, in § 761.75(b)(8)(iii) (see above). ASTM began building its electronic library of standards in the 1990s, so the 1987 version of ASTM D482 and the 1989 version of ASTM D3278 are no longer available from the ASTM website. Therefore, the Agency is updating ASTM D482-87 and ASTM D3278-89 to list the most recent versions of the methods.</P>
                    <P>Furthermore, EPA requests public comment on whether there are other standards that should be incorporated by reference or whether there are standards that should be removed from the regulations entirely. EPA is relying on voluntary consensus standards developed by ASTM and already in use in the laboratory testing sector, which is consistent with the National Technology Transfer and Advancement Act (NTTAA). EPA has found that most of the entities that would have to comply with these standards are already familiar with them, since it would be difficult to be in the business of testing for PCBs without being familiar with these industry consensus standards. The standards are all readily available electronically or in print and are relatively inexpensive. See proposed § 761.19.</P>
                    <HD SOURCE="HD3">Require a Wipe Sample Under § 761.30(i)(4)</HD>
                    <P>
                        Currently, § 761.30(i)(4) (covering PCB characterization of natural gas pipe) reads, in part, “. . . if no liquids are present, they must use standard wipe samples in accordance with Subpart M of this part.” This language might be read to mean that all owners of natural gas pipe must characterize their pipe and must do so using a wipe sample if no liquids are present. However, the sentence was meant to convey that if an owner 
                        <E T="03">chooses</E>
                         to characterize natural gas pipe that does not contain liquids, they must do so using wipe samples. Therefore, EPA is proposing to replace the existing text with “if no liquids are present and they decide, in their discretion, to characterize PCB contamination, the person must use standard wipe samples 
                        <PRTPAGE P="58748"/>
                        in accordance with Subpart M of this part.” See proposed § 761.30(i)(4).
                    </P>
                    <HD SOURCE="HD3">High Efficiency Boilers Approval Application Requirements</HD>
                    <P>
                        EPA is proposing to correct an editorial error in § 761.71. This section describes the required operating parameters for high efficiency boilers that dispose of PCB waste. The requirements for high efficiency boilers are divided into two sections, a section for burning PCB-contaminated mineral oil dielectric fluid (§ 761.71(a)) and a section for burning any other PCB-contaminated fluids (§ 761.71(b)). Mineral oil dielectric fluid is an insulating fluid used in electrical equipment such as transformers. Other PCB-contaminated fluids might include used oil, contaminated water, and hydraulic fluid. Despite the fact that § 761.71(b) regulates high efficiency boilers that burn PCB liquids 
                        <E T="03">other</E>
                         than mineral oil dielectric fluid, § 761.71(b)(2)(iv) requires persons seeking approval to burn these liquids to submit to the EPA Regional Administrator a statement of “the type of equipment, apparatus, and procedures to be used to control the feed of 
                        <E T="03">mineral oil dielectric fluid</E>
                         to the boiler . . .” (emphasis added). In that sentence, “mineral oil dielectric fluid” should, instead, be “PCB liquids.” This proposal would amend § 761.71(b)(2)(iv) to correct this error by replacing the phrase “mineral oil dielectric fluid” with “PCB liquids.” See proposed § 761.71(b)(2)(iv).
                    </P>
                    <HD SOURCE="HD3">Mailing Address for Annual Reports</HD>
                    <P>
                        Currently, the owner or operator of any PCB disposal facility or commercial storage facility submits an annual report to the EPA Regional Administrator for the region in which the facility is located, pursuant to § 761.180(b)(3). EPA proposes to change the recipient of the annual reports from the Regional Administrator to the Director of the Office of Resource Conservation and Recovery, which is the office in EPA headquarters that manages the PCB cleanup and disposal program. An analogous change is also proposed in § 761.3 under the definition of 
                        <E T="03">annual report.</E>
                         This change would reduce the administrative burden on the Agency of compiling the data in the annual reports, which is used to inform Agency actions. The address for submission would be displayed prominently on the proposed mandatory form. See proposed §§ 761.3 and 761.180(b)(3).
                    </P>
                    <HD SOURCE="HD3">Update Address for Submission of EPA Form 7710-53</HD>
                    <P>EPA proposes to remove the address for EPA form 7710-53, “Notification of PCB Activity,” from the regulations. This change will allow EPA to more easily update the mailing address in the future without undergoing a regulatory change. The mailing address will continue to appear on the form itself and can be updated through the Information Collection Response (ICR) process. This proposed change would expedite future address changes and thus streamline the distribution of mail and reduce the processing time for these forms. See proposed § 761.205(a)(3), § 761.205(d).</P>
                    <HD SOURCE="HD3">Add Field for Facility Email Address and EPA PCB Email Address to EPA Form 7710-53</HD>
                    <P>
                        EPA form 7710-53, “Notification of PCB Activity,” currently does not include space for an email address for the facility point of contact. EPA proposes to change the regulations so that an email address must be submitted on the notification form. Additionally, EPA is adding the EPA PCB email address (
                        <E T="03">ORCRPCBs@epa.gov</E>
                        ) to the notification form to facilitate any questions from members of the public. These proposed changes would improve communication and reduce the processing time for these forms. See proposed § 761.205(a)(3), § 761.205(d).
                    </P>
                    <HD SOURCE="HD3">Sample Site Selection Instructions for Pipelines</HD>
                    <P>Subpart M provides a number of steps that must be followed when selecting the locations for sampling to characterize natural gas pipeline. EPA found that, due to rounding errors, the instructions for a pipeline greater than seven segments but shorter than three miles in length are, at present, incorrect. EPA proposes to modify the instructions and the example given in § 761.247(b)(2)(ii)(B) to clarify where each sample must be taken along pipelines of this length. This change is a technical correction and does not influence the number of samples taken or the burden on the owner of the pipe. See proposed § 761.247(b)(2)(ii)(B).</P>
                    <HD SOURCE="HD3">Remove Reference to Method 3500B</HD>
                    <P>
                        SW-846 is organized such that several similar methods are grouped together in a series and the 3500 series contains extraction procedures used for the preparation of samples for analysis of organic parameters. These techniques include Liquid-Liquid Extraction, Solid-Phase Extraction, Soxhlet Extraction, and Supercritical Fluid Extraction, among others. Method 3500B (recently updated to Method 3500C) is not a detailed method where step-by-step instructions are discussed.
                        <E T="51">78 79</E>
                        <FTREF/>
                         Rather, Method 3500B simply provides general guidance for all the methods within its series (
                        <E T="03">i.e.,</E>
                         3500 series), including the extraction methods proposed to be added as part of this rulemaking. Also, Method 3500B or 3500C is already referenced in every 3500 series method EPA is proposing to add to the PCB Regulations. Therefore, EPA feels that it is unnecessary to reference Method 3500B in the PCB regulations directly and proposes to remove the reference from the PCB regulations. The removal of Method 3500B from the regulations would not influence any of the 3500 series methods currently in or proposed to be added to the PCB regulations. The PCB regulatory sections affected include §§ 761.61(a)(5)(i)(B)(
                        <E T="03">2</E>
                        )(
                        <E T="03">iv</E>
                        ), 761.253, 761.272, 761.292, 761.358, and 761.395.
                    </P>
                    <FTNT>
                        <P>
                            <SU>78</SU>
                             U.S. EPA, Method 3500B Organic Extraction and Sample Preparation. Office of Land and Emergency Management, Office of Resource Conservation and Recovery, Materials Recovery and Waste Management Division (5303P). Washington, DC. December 1996.
                        </P>
                        <P>
                            <SU>79</SU>
                             U.S. EPA, Method 3500C Organic Extraction and Sample Preparation. Office of Land and Emergency Management, Office of Resource Conservation and Recovery, Materials Recovery and Waste Management Division (5303P). Washington, DC. February 2007.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Correct References to SW-846</HD>
                    <P>The official title of the EPA publication known as SW-846 has been updated from “Test Methods for Evaluating Solid Waste” to “Test Methods for Evaluating Solid Waste: Physical/Chemical Methods.” There are several references to this publication throughout the PCB regulations. EPA proposes to update the definition of SW-846 in § 761.3 with the current official title, and then refer to it as “SW-846” throughout the PCB regulations, for readability. See proposed §§ 761.3, 761.60(g)(1)(iii), 761.61(a)(5)(i)(B)(2)(iv), 761.253(a), 761.272, 761.292, 761.358, 761.395(b)(1).</P>
                    <HD SOURCE="HD3">Correct References to EPA's PCB Website</HD>
                    <P>
                        There are several references throughout the PCB regulations to the EPA's PCB website. In 2015, as part of a redesign, the URL for the EPA PCB web page changed from 
                        <E T="03">https://www.epa.gov/pcb</E>
                         to 
                        <E T="03">https://www.epa.gov/pcbs.</E>
                         EPA proposes to update those references throughout the PCB regulations. See proposed §§ 761.130(e), 761.205(a)(3), 761.243(a), 761.386(e).
                        <PRTPAGE P="58749"/>
                    </P>
                    <HD SOURCE="HD3">Change “he” to “they”</HD>
                    <P>The PCB regulations frequently refer to generic individuals such as the Regional Administrator or facility owners as “he,” “his,” “he/she,” or “he or she.” EPA proposes to replace all such references with the gender neutral “they” and “their.” See proposed §§ 761.3, 761.20(e)(3)(ii)(B), 761.20(e)(4)(i), 761.20(e)(4)(ii), 761.50(b)(3)(i)(A), 761.60(b)(2)(v)(C), 761.61(a)(8)(i)(B), 761.65(g), 761.65(h), 761.70(d)(4)(i), 761.75(c)(3)(i), 761.75(c)(4), 761.77(a)(1)(ii)(B), 761.77(a)(2), 761.77(b), 761.120(b)(2), 761.125(c)(3)(iii), 761.125(c)(4)(iv), 761.180(b)(4), 761.207(c), 761.212(a), 761.213(a)(4), 761.213(b), 761.214(a), 761.216(a), 761.217(a)(2)(ii).</P>
                    <HD SOURCE="HD3">Change “on site” to “on-site”</HD>
                    <P>The term “on site” is included in the definitions at § 761.3, but the PCB regulations use the term “on-site” throughout. EPA proposes to modify § 761.3 to read “on-site” to improve the readability of the PCB regulations. See proposed § 761.3.</P>
                    <HD SOURCE="HD3">Correct Reference to Methods for Standard Wipe Test Samples</HD>
                    <P>Currently, § 761.314 “Chemical analysis of standard wipe test samples” instructs the reader to “perform the chemical analysis of standard wipe test samples in accordance with § 761.272.” While § 761.272 does contain the allowable methods for wipe test samples, it also lists several other methods that would not be appropriate for wipe test samples. This reference is proposed to be corrected to § 761.253, which is specific to wipe samples.</P>
                    <HD SOURCE="HD3">Incorporation by Reference</HD>
                    <P>
                        The Agency is proposing to incorporate by reference SW-846 Test Methods 3540C, 3541, 3545A, 3546, 3510C, 3520C, 3535A, 8082, 8082A, and 8275A into 40 CFR part 761 under §§ 761.60, 761.61, 761.253, 761.272, 761.292, 761.358, and 761.395. The Agency is also proposing to incorporate by reference Clean Water Act Analytical Method 1668C into 40 CFR part 761 under §§ 761.60, 761.61, 761.253, 761.272, 761.292, 761.358, and 761.395. These test methods are described in detail in 
                        <E T="03">Section III.A. Expand Available Extraction Methods for PCBs</E>
                         and 
                        <E T="03">Section III.C. Add Determinative Methods for the PCB Regulations,</E>
                         above. The Agency is also proposing to incorporate the following methods by refence that involve testing the flash points of liquids to evaluate the ignitability of liquid wastes: ASTM standards D3278-96 (Reapproved 2011), D8174-18, and D8175-18. ASTM D3278-96 (Reapproved 2011) uses a small-scale tester to determine the flash point, ASTM D8174-18 also uses a small-scale tester but tests whether a material does or does not flash at a specific temperature, and ASTM D8175-18 uses a Pensky-Martens tester to determine the flash point. Likewise, the Agency is proposing to incorporate by reference ASTM standard D482-13, which determines the percentage of ash generated from distillate and residual fuels, gas turbine fuels, crude oils, lubricating oils, waxes, and other petroleum products. The Agency is also proposing to incorporate by reference ASTM Standard D4059-00 (R18), which is a quantitative determination of the concentration of polychlorinated biphenyls (PCBs) in electrical insulating liquids by gas chromatography. Lastly, the Agency is proposing to incorporate by reference ASTM Standard D5373-16, which is used to determine the concentration of hydrogen and nitrogen in analysis samples of coal and of carbon in analysis samples of coal and coke. These methods will be incorporated by reference into 40 CFR part 761 under §§ 761.60, 761.71, and 761.75.
                    </P>
                    <P>ASTM D93-09, D129-64, D240-87, D524-88, D808-87, D923-86, D923-89, D1266-87, D1796-83, D2158-89, D2709-88, and E258-67 (Reapproved 1987) were previously approved for incorporation by reference on January 18, 2012.</P>
                    <P>
                        The SW-846 Test Methods proposed for incorporation by reference are published in the test methods compendium known as, “Test Methods for Evaluating Solid Waste, Physical/Chemical Methods,” EPA Publication SW-846, Third Edition, available at 
                        <E T="03">https://www.epa.gov/hw-sw846.</E>
                         The Clean Water Act Analytical Methods are available at 
                        <E T="03">https://www.epa.gov/cwa-methods.</E>
                         ASTM materials may be obtained from ASTM International, 100 Barr Harbor Dr., P.O. Box C700, West Conshohocken, PA 19428-2959, or by calling (877) 909-ASTM, or at 
                        <E T="03">https://www.astm.org.</E>
                         All methods proposed for incorporation by reference are also included in the docket.
                    </P>
                    <HD SOURCE="HD1">IV. Economic Impacts of the Proposed Rulemaking</HD>
                    <P>One focus of the proposed rule is expanding the allowable PCB extraction methods, which would impact testing laboratories (NAICS code 541380) that currently perform PCB extractions under TSCA. Based on method-specific certifications and communication with laboratory personnel, EPA estimates that approximately 22 laboratories would be impacted by the proposed rule. Further, EPA estimates that these 22 laboratories perform approximately 65,000 relevant extractions each year. Some laboratories may experience a one-time cost of purchasing equipment used to perform one of the proposed extraction methods. However, the decreases in solvent and labor hours required to perform the proposed extraction methods are expected to result in net annual cost savings of approximately $4.2 million (annualized at a discount rate of seven percent).</P>
                    <P>Updating the permissible PCB determinative methods would offer the regulated community greater flexibility. However, EPA does not anticipate that it would have an economic impact, since most labs are expected to continue using EPA Method 8082 or EPA Method 8082A as their PCB determinative method.</P>
                    <P>
                        The proposed revisions to § 761.61(b) may impact any facility performing a PCB site remediation under § 761.61(b). No data are available on the exact number of § 761.61(b) remediations performed annually, but EPA estimates that there would be between 430 and 460 relevant remediations per year, based on an analysis of 2018 and 2019 hazardous waste manifests. Certain aspects of this provision would increase burden on the regulated community through certain requirements (
                        <E T="03">e.g.,</E>
                         recordkeeping, notification, sampling). However, EPA also proposes to allow for disposal of relevant waste at RCRA Subtitle C landfills under § 761.61(b), in addition to the existing disposal options (
                        <E T="03">e.g.</E>
                         TSCA landfills, TSCA incinerators), which will decrease transportation and disposal costs related to non-hazardous, non-liquid PCB waste for the regulated community. Overall, the proposed revisions to § 761.61(b) are expected to result in net annual cost savings between $9.2 million and $10.9 million (annualized at a discount rate of seven percent).
                    </P>
                    <P>
                        Disallowing PCB bulk product waste to be used as roadbed has the potential to create a slight increase in costs for the regulated community. Facilities that would have used PCB bulk product waste on-site as roadbed under asphalt would now have to pay to transport the waste to a municipal solid waste landfill and pay the associated tipping fee for disposal. EPA believes that the practice of using PCB bulk product waste as roadbed is exceedingly rare. However, in an effort to incorporate all potential impacts of the proposed rule, the Economic Assessment modeled a single party using PCB bulk product waste as roadbed per year. EPA estimates that the cost increase for the regulated 
                        <PRTPAGE P="58750"/>
                        community would be between $660 and $5,950 per year.
                    </P>
                    <P>EPA anticipates that the added flexibilities for emergency situations would result in cost savings for the regulated community. EPA estimates that there would be between 12 and 60 emergencies each year where the regulated community may use the proposed flexibilities. A lack of data prevents an overall quantitative estimate of the cost savings from this provision. However, impacted parties are expected to save money and time by avoiding delays associated with searches for the source of the spill during an emergency situation where the search is likely to be time-consuming and unsuccessful, and by being able to manage waste under the less burdensome procedures of § 761.125(b), rather than § 761.125(c). The regulated community is also expected to see a decrease in sampling and testing expenditures.</P>
                    <P>The proposed change to harmonize the general disposal requirements for PCB remediation waste is in line with current EPA policy, guidance and practice. Therefore, EPA estimates that this change will not have any economic impact.</P>
                    <P>The Economic Assessment for the proposed rule is constrained by the lack of relevant data, largely because the proposed rule makes changes to provisions that are self-implementing and/or require no EPA notification. EPA has quantified costs and cost savings when possible. When quantification has not been possible, EPA has analyzed the costs and cost savings qualitatively. The Economic Assessment associated with the proposed rule can be referenced for a greater level of detail related to the costs and benefits of the proposed provisions. EPA requests comments and data related to the universe of parties impacted by the proposed provisions and the economic impact of the proposed rule.</P>
                    <HD SOURCE="HD1">V. 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 Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review</HD>
                    <P>
                        This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review under Executive Order 12866 (58 FR 51735, October 4, 1993) and Executive Order 13563 (76 FR 3821, January 21, 2011). Any changes made in response to OMB recommendations have been documented in the docket. The Economic Assessment is available in the docket and is summarized in 
                        <E T="03">Section I.D What are the projected economic impacts of this action?</E>
                         of the preamble.
                    </P>
                    <HD SOURCE="HD2">B. Paperwork Reduction Act (PRA)</HD>
                    <P>
                        The information collection activities in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB) under the PRA, 44 U.S.C. 3501 
                        <E T="03">et seq.</E>
                         The Information Collection Request (ICR) document that the EPA prepared has been assigned EPA ICR number 2688.01 (2050-NEW). You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here.
                    </P>
                    <P>
                        <E T="03">Respondents/affected entities:</E>
                         The information collection requirements of the proposed rule affect facilities that will read the proposed rule, responsible parties using § 761.61(b)(1) performance-based cleanup, responsible parties using § 761.66 waivers in emergency situations, commercial storers and disposers submitting annual reports, and entities submitting Notification of PCB Activity forms.
                    </P>
                    <P>
                        <E T="03">Respondent's obligation to respond:</E>
                         The recordkeeping and notification requirements are required for parties performing relevant activities (
                        <E T="03">e.g.</E>
                         using § 761.66 waivers in emergency situations). These requirements are described in detail in the ICR Supporting Statement.
                    </P>
                    <P>
                        <E T="03">Estimated number of respondents:</E>
                         1,085.
                    </P>
                    <P>
                        <E T="03">Frequency of response:</E>
                         On occasion/as necessary.
                    </P>
                    <P>
                        <E T="03">Total estimated burden:</E>
                         8,276 hours.
                    </P>
                    <P>
                        <E T="03">Total estimated cost:</E>
                         $979,187.
                    </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 the EPA's regulations in 40 CFR are listed in 40 CFR part 9. 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 the EPA using the docket identified at the beginning of this rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs via email to 
                        <E T="03">OIRA_submission@omb.eop.gov,</E>
                         Attention: Desk Officer for EPA. Since OMB is required to make a decision concerning the ICR between 30 and 60 days after receipt, OMB must receive comments no later than November 22, 2021. The EPA will respond to any ICR-related comments in the final rule.
                    </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 RFA, 5 U.S.C. 601 
                        <E T="03">et seq.</E>
                         In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves burden or has no net burden on the small entities subject to the rule. These proposed changes would reduce the impacts on all small entities subject to the rule, so there are no significant impacts to any small entities. We have therefore concluded that this action will relieve regulatory burden for all directly regulated small entities. Details of this analysis are presented in the Economic Assessment, which is in the public docket for this action.
                    </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. EPA estimates that the proposed rule would result in net annual cost savings of between $4.3 and $9.1 million, assuming a seven percent discount rate. As a result, EPA expects that the rule would not result in annual expenditures exceeding $100 million annually and therefore would not be subject to requirements of section 202 of UMRA as listed above.</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 (65 FR 67249, November 9, 2000) because the action is not expected to result in any adverse environmental or human health impacts on tribal entities. In addition, the action is expected to result in a cost savings, and not expected to result in any adverse financial impacts on tribal entities. Thus, Executive Order 13175 does not 
                        <PRTPAGE P="58751"/>
                        apply to this rule. Consistent with the EPA Policy on Consultation and Coordination with Indian Tribes, the EPA prepared a tribal consultation and coordination plan and sent a letter to the tribes on July 13, 2021, inviting consultation. EPA will provide a summary of any tribal consultation conducted in the docket.
                    </P>
                    <HD SOURCE="HD2">G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks</HD>
                    <P>This action is not subject to Executive Order 13045 (62 FR. 19885, April 23, 1997) because it is not an economically significant regulatory action as defined by Executive Order 12866. In addition, because the rule would not increase risk related to exposure to hazardous materials, the Agency does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children.</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” under Executive Order 13211, “Actions Concerning Regulations that Affect Energy Supply, Distribution, or Use” (May 18, 2001) because it is not likely to have a significant adverse effect on the supply, distribution or use of energy. The proposed rule would not directly regulate energy production or consumption and is expected to result in net cost savings.</P>
                    <HD SOURCE="HD2">I. National Technology Transfer and Advancement Act (NTTAA)</HD>
                    <P>
                        This action involves technical standards. In this rulemaking, the EPA incorporates voluntary consensus standards (VCSs) developed by both ASTM and the Agency into the rulemaking, consistent with the National Technology Transfer and Advancement Act (NTTAA). These VCSs support PCB cleanups as well sampling activities including the extraction and analysis of PCBs. For more details on the technical standards that EPA is using in this rulemaking, please see 
                        <E T="03">Section III.G—Incorporation by Reference.</E>
                    </P>
                    <HD SOURCE="HD2">J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations</HD>
                    <P>EPA believes that this action does not have disproportionately high and adverse health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). In fact, this action is expected to benefit these populations.</P>
                    <P>Generally, the proposed rule would modernize PCB regulations, making it easier and more affordable to clean up contaminated sites, while continuing to ensure that the requirements remain protective of health and the environment. Underserved, disadvantaged, and overburdened communities are expected to benefit from quicker, more cost-effective, compliant cleanups under the proposed rule. For example, adding explicit cleanup provisions under § 761.61(b), including the requirements to notify EPA and follow specific sampling protocols, would provide additional assurance that sites are properly remediated and enable compliance and enforcement. Furthermore, the increased flexibility in emergency situations would allow the Agency to work collaboratively with responsible parties during and after the response to a natural disaster or other emergency, which can disproportionately impact such communities.</P>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects in 40 CFR Part 761</HD>
                        <P>Environmental protection, Hazardous substances, Incorporation by reference, Labeling, Polychlorinated biphenyls (PCBs), Reporting and recordkeeping requirements.</P>
                    </LSTSUB>
                    <SIG>
                        <NAME>Barry N. Breen,</NAME>
                        <TITLE>Acting Assistant Administrator, Office of Land and Emergency Management.</TITLE>
                    </SIG>
                    <P>For the reasons set out in the preamble, EPA proposes to amend title 40, chapter I of the Code of Federal Regulations, part 761 as follows:</P>
                    <PART>
                        <HD SOURCE="HED">PART 761—POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, PROCESSING, DISTRIBUTION IN COMMERCE, AND USE PROHIBITIONS</HD>
                    </PART>
                    <AMDPAR>1. In part 761, the authority citation continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>15 U.S.C. 2605, 2607, 2611, 2614, and 2616.</P>
                    </AUTH>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart A—General</HD>
                    </SUBPART>
                    <AMDPAR>2. Amend § 761.1 by revising paragraph (b)(3) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.1</SECTNO>
                        <SUBJECT> Applicability.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>
                            (3) Most provisions in this part apply only if PCBs are present in concentrations above a specified level. Provisions that apply to PCBs at concentrations of &lt;50 ppm apply also to contaminated surfaces at PCB concentrations of &lt;10 μg/100 cm
                            <SU>2</SU>
                            . Provisions that apply to PCBs at concentrations of ≥50 to &lt;500 ppm apply also to contaminated surfaces at PCB concentrations of ≥10 μg/100 cm
                            <SU>2</SU>
                             to &lt;100 μg/100 cm
                            <SU>2</SU>
                            . Provisions that apply to PCBs at concentrations of ≥500 ppm apply also to contaminated surfaces at PCB concentrations of ≥100 μg/100 cm
                            <SU>2</SU>
                            .
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>3. Amend § 761.3 by:</AMDPAR>
                    <AMDPAR>a. Removing in the definition the words“On site” and adding in its place the words “On-site”;</AMDPAR>
                    <AMDPAR>b. Adding in alphabetical order the definitions “As-found concentration”, “CWA”, “Director, Office Resource Conservation and Recovery”, and “Emergency situation”; and</AMDPAR>
                    <AMDPAR>c. Revising the definitions “Administrator”, “Annual report”, “ASTM”, “NTIS”, “Non-porous surface”, and “SW-846”.</AMDPAR>
                    <P>The revisions and additions read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 761.3</SECTNO>
                        <SUBJECT> Definitions.</SUBJECT>
                        <STARS/>
                        <P>
                            <E T="03">Administrator</E>
                             means the Administrator of the Environmental Protection Agency, or any employee of the Agency to whom the Administrator may either herein or by order delegate their authority to carry out their functions, or any person who shall by operation of law be authorized to carry out such functions.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Annual report</E>
                             means the completed EPA Form 6200-025 submitted each year by each disposer and commercial storer of PCB waste to the Director, Office of Resource Conservation and Recovery. The annual report is a brief summary of the information included in the annual document log.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">As-found concentration</E>
                             means the concentration measured in samples collected in-situ (
                            <E T="03">i.e.,</E>
                             prior to being moved or disturbed for cleanup and/or disposal) from environmental media or material, unless otherwise specifically provided. For example, media must not be disturbed, nor may they be diluted (
                            <E T="03">e.g.,</E>
                             excavated, placed on a pile, and sampled after such placement) before characterization sampling is conducted. Sampling media in piles and existing accumulations would be considered “as-found” if the media were already in piles when the site was first visited by the responsible party, such as during the redevelopment of abandoned properties with historic PCB contamination. The as-found concentration is distinct from the source concentration, which is the 
                            <PRTPAGE P="58752"/>
                            concentration of the PCBs in the material that was originally spilled, released, or otherwise disposed of at the site.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">ASTM</E>
                             means ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">CWA</E>
                             means Clean Water Act, also known as the Federal Waters Pollution Control Act Amendments of 1972 (33 U.S.C. 12-51-1387, amended ch.23 1151).
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Director, Office Resource Conservation and Recovery</E>
                             means the Director of the Office of Resource Conservation and Recovery of the Office of Land and Emergency Management of the United States Environmental Protection Agency. Submissions to the Director shall be sent to 1200 Pennsylvania Ave. NW, MC5303P, Washington, DC 20460.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Emergency situation</E>
                             means adverse conditions caused by manmade or natural incidents that threaten lives, property, or public health and safety; require prompt responsive action from the local, state, tribal, territorial, or federal government; and result in: (1) A declaration by either the President of the United States or Governor of the affected state of a natural disaster or emergency; or, (2) an incident funded under the Federal Emergency Management Agency (FEMA) via a Stafford Act disaster declaration or emergency declaration. Examples of emergency situations may include civil emergencies or adverse natural conditions, such as hurricanes, earthquakes, or tornados.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">NTIS</E>
                             means the National Technical Information Service, 1401 Constitution Ave NW, Washington, DC 20230, telephone: (703) 605-6060.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Non-porous surface</E>
                             means a smooth, unpainted solid surface that limits penetration of liquid containing PCBs beyond the immediate surface. Examples are: Smooth uncorroded metal; natural gas pipe with a thin porous coating originally applied to inhibit corrosion; smooth glass; smooth glazed ceramics; impermeable polished building stone such as marble or granite; and medium- and high-density plastics, such as polycarbonates and melamines, that do not absorb solvents.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">SW-846</E>
                             means the document having the title “SW-846, Test Methods for Evaluating Solid Waste: Physical/Chemical Methods,” also known as the SW-846 Compendium, which is available online at 
                            <E T="03">https://www.epa.gov/hw-sw846.</E>
                             Hard copies can be obtained from NTIS, U.S. Department of Commerce, 1401 Constitution Ave NW, Washington, DC 20230, telephone: (703) 605-6060.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>4. Revise § 761.19 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.19</SECTNO>
                        <SUBJECT> Incorporation by reference.</SUBJECT>
                        <P>
                            The materials listed in this section are incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection at the EPA Docket Center (EPA/DC), Rm. 3334, EPA West Bldg., 1301 Constitution Ave. NW, Washington, DC 20460-0001, (202) 566-1744, and is available from the sources listed in the following paragraphs of this section. It is also available for inspection 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>
                        <P>
                            (a) 
                            <E T="03">ASTM International.</E>
                             100 Barr Harbor Dr., P.O. Box C700, West Conshohocken, PA 19428-2959, (877) 909-ASTM, 
                            <E T="03">www.astm.org.</E>
                        </P>
                        <P>(1) ASTM D93-09, Standard Test Methods for Flash Point by Pensky-Martens Closed Tester, Approved December 15, 2009, IBR approved for §§ 761.71 and 761.75.</P>
                        <P>(2) ASTM D129-64, Standard Test Method for Sulfur in Petroleum Products (General Bomb Method), Reapproved 1978, IBR approved for § 761.71.</P>
                        <P>(3) ASTM D240-87, Standard Test Method for Heat of Combustion of Liquid Hydrocarbon Fuel by Bomb Calorimeter, Approved 1987, IBR approved for § 761.71.</P>
                        <P>(4) ASTM D482-13, Standard Test Method for Ash from Petroleum Products, Approved June 2013, IBR approved for § 761.71.</P>
                        <P>(5) ASTM D524-88, Standard Test Method for Ramsbottom Carbon Residue of Petroleum Products, Approved 1988, IBR approved for § 761.71.</P>
                        <P>(6) ASTM D808-87, Standard Test Method for Chlorine in New and Used Petroleum Products (Bomb Method), Approved 1987, IBR approved for § 761.71.</P>
                        <P>(7) ASTM D923-86, Standard Test Method for Sampling Electrical Insulating Liquids, Approved 1986, IBR approved for § 761.60.</P>
                        <P>(8) ASTM D923-89, Standard Methods of Sampling Electrical Insulating Liquids, Approved 1989, IBR approved for § 761.60.</P>
                        <P>(9) ASTM D1266-87, Standard Test Method for Sulfur in Petroleum Products (Lamp Method), October 1987, IBR approved for § 761.71.</P>
                        <P>(10) ASTM D1796-83, Standard Test Method for Water and Sediment in Fuel Oils by the Centrifuge Method (Laboratory Procedure), Reapproved 1990, IBR approved for § 761.71.</P>
                        <P>(11) ASTM D2158-89, Standard Test Method for Residues in Liquified Petroleum (LP) Gases, Approved 1989, IBR approved for § 761.71.</P>
                        <P>(12) ASTM D2709-88, Standard Test Method for Water and Sediment in Distillate Fuels by Centrifuge, Approved 1988, IBR approved for § 761.71.</P>
                        <P>(13) ASTM D3278-96 (Reapproved 2011), Standard Test Methods for Flash Point of Liquids by Small Scale Closed-Cup Apparatus, Approved June 2011, IBR approved for § 761.75.</P>
                        <P>(14) ASTM Standard D4059-00 (Reapproved 2018), Standard Test Method for Analysis of Polychlorinated Biphenyls in Insulating Liquids by Gas Chromatography, Approved December 2018, IBR approved for § 761.60.</P>
                        <P>(15) ASTM D5373-16, Standard Test Methods for Determination of Carbon, Hydrogen and Nitrogen in Analysis Samples of Coal and Carbon in Analysis Samples of Coal and Coke, Approved September 2016, IBR approved for § 761.71.</P>
                        <P>(16) ASTM D8174-18, Test Method for Finite Flash Point Determination of Liquid Wastes by Small Scale Closed Cup Tester, Approved March 2018, IBR approved for §§ 761.71 and 761.75.</P>
                        <P>(17) ASTM D8175-18, Test Method for Finite Flash Point Determination of Liquid Wastes by Pensky-Martens Closed Cup Tester, IBR approved for §§ 761.71 and 761.75.</P>
                        <P>(18) ASTM E258-67 (Reapproved 1987), Standard Test Method for Total Nitrogen Inorganic Material by Modified KJELDAHL Method, Approved 1987, IBR approved for § 761.71.</P>
                        <P>
                            (b) 
                            <E T="03">U.S. Environmental Protection Agency material.</E>
                             1200 Pennsylvania Avenue NW, Washington, DC 20460, (202) 272-0167, 
                            <E T="03">www.epa.gov; https://www.epa.gov/cwa-methods</E>
                             and 
                            <E T="03">https://www.epa.gov/hw-sw846.</E>
                             (Note: For hard copies of these materials, contact: National Technical Information Service, U.S. Department of Commerce, 5285 Port Royal Rd., Springfield, VA 22161, (800) 553-6847 or (703) 605-6000.) .
                        </P>
                        <P>
                            (1) CWA Method 1668C, Chlorinated Biphenyl Congeners in Water, Soil, Sediment, Biosolids, and Tissue by HRGC/HRMS, Approved April 2010, 
                            <PRTPAGE P="58753"/>
                            IBR approved for §§ 761.61, 761.253, 761.272, 761.292, 761.358, and 761.395.
                        </P>
                        <P>(2) SW-846 Method 3510C, Separatory Funnel Liquid-Liquid Extraction, Approved December 1996, IBR approved for §§ 761.61, 761.272, and 761.292.</P>
                        <P>(3) SW-846 Method 3520C, Continuous Liquid-Liquid Extraction, Approved December 1996, IBR approved for §§ 761.61, 761.272, and 761.292.</P>
                        <P>(4) SW-846 Method 3535A, Solid-Phase Extraction (SPE), Approved February 2007, IBR approved for §§ 761.61, 761.272, and 761.292.</P>
                        <P>(5) SW-846 Method 3540C, Soxhlet Extraction, Approved December 1996, IBR approved for §§ 761.61, 761.253, 761.272, 761.292, 761.358, and 761.395.</P>
                        <P>(6) SW-846 Method 3541, Automated Soxhlet Extraction, Approved September 1994, IBR approved for §§ 761.61, 761.253, 761.272, 761.292, 761.358, and 761.395.</P>
                        <P>(7) SW-846 Method 3545A, Pressurized Fluid Extraction (PFE), Approved January 1998, IBR approved for §§ 761.61, 761.253, 761.272, 761.292, 761.358, and 761.395.</P>
                        <P>(8) SW-846 Method 3546, Microwave Extraction, Approved February 2007, IBR approved for §§ 761.61, 761.253, 761.272, 761.292, 761.358, and 761.395.</P>
                        <P>(9) SW-846 Method 8082, Polychlorinated Biphenyls (PCBs) By Gas Chromatography, Approved December 1996, IBR approved for §§ 761.61, 761.253, 761.272, 761.292, 761.358, and 761.395.</P>
                        <P>(10) SW-846 Method 8082A, Polychlorinated Biphenyls (PCBs) By Gas Chromatography, Approved February 2007, IBR approved for §§ 761.60, 761.61, 761.253, 761.272, 761.292, 761.358, and 761.395.</P>
                        <P>(11) SW-846 Method 8275A, Semivolatile Organic Compounds (PAHs And PCBs) in Soils/Sludges and Solid Wastes Using Thermal Extraction/Gas Chromatography/Mass Spectrometry (TE/GC/MS), Approved December 1996, IBR approved for §§ 761.61, 761.253, 761.272, 761.292, 761.358, and 761.395.</P>
                    </SECTION>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart B—Manufacturing, Processing, Distribution in Commerce, and Use of PCBs and PCB Items</HD>
                    </SUBPART>
                    <AMDPAR>5. Amend § 761.20 by revising paragraphs (e)(3)(ii)(B), (4)(i), and (ii) as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.20</SECTNO>
                        <SUBJECT> Prohibitions and exceptions.</SUBJECT>
                        <STARS/>
                        <P>(e) * * *</P>
                        <P>(3) * * *</P>
                        <P>(ii) * * *</P>
                        <P>(B) The burner will burn the used oil only in a combustion facility identified in paragraph (e)(1) of this section and identify the class of burner they qualify under.</P>
                        <STARS/>
                        <P>(4) * * *</P>
                        <P>
                            (i) 
                            <E T="03">Marketers.</E>
                             Marketers who first claim that the used oil fuel contains no detectable PCBs must include among the records required by 40 CFR 279.72(b) and 279.74(b) and (c), copies of the analysis or other information documenting their claim, and they must include among the records required by 40 CFR 279.74(a) and (c) and 279.75, a copy of each certification notice received or prepared relating to transactions involving PCB-containing used oil.
                        </P>
                        <P>
                            (ii) 
                            <E T="03">Burners.</E>
                             Burners must include among the records required by 40 CFR 279.65 and 279.66, a copy of each certification notice required by paragraph (e)(3)(ii) of this section that they send to a marketer.
                        </P>
                    </SECTION>
                    <AMDPAR>6. Amend § 761.30 by revising paragraph (i)(4) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.30</SECTNO>
                        <SUBJECT> Authorizations.</SUBJECT>
                        <STARS/>
                        <P>(i) * * *</P>
                        <P>(4) Any person characterizing PCB contamination in natural gas pipe or natural gas pipeline systems must do so by analyzing organic liquids collected at existing condensate collection points in the pipe or pipeline system. The level of PCB contamination found at a collection point is assumed to extend to the next collection point downstream. Any person characterizing multi-phasic liquids must do so in accordance with § 761.1(b)(4); if no liquids are present and they choose, in their discretion, to characterize PCB contamination, the person must use standard wipe samples in accordance with subpart M of this part.</P>
                        <STARS/>
                    </SECTION>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart D—Storage and Disposal</HD>
                    </SUBPART>
                    <AMDPAR>7. Amend § 761.50 by revising paragraphs (b)(3)(i)(A) and (3)(ii) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.50</SECTNO>
                        <SUBJECT> Applicability.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(3) * * *</P>
                        <P>(i) * * *</P>
                        <P>(A) Sites containing these wastes are presumed not to present an unreasonable risk of injury to health or the environment from exposure to PCBs at the site. However, the EPA Regional Administrator may inform the owner or operator of the site that there is reason to believe that spills, leaks, or other uncontrolled releases or discharges, such as leaching, from the site constitute ongoing disposal that may present an unreasonable risk of injury to health or the environment from exposure to PCBs at the site, and may require the owner or operator to generate data necessary to characterize the risk. If after reviewing any such data, the EPA Regional Administrator makes a finding, that an unreasonable risk exists, then they may direct the owner or operator of the site to dispose of the PCB remediation waste in accordance with § 761.61 such that an unreasonable risk of injury no longer exists.</P>
                        <STARS/>
                        <P>(ii) Any person responsible for PCB waste that was either placed in a land disposal facility, spilled, or otherwise released into the environment on or after April 18, 1978, but prior to July 2, 1979, where the concentration of the spill or release was ≥500 ppm; or placed in a land disposal facility, spilled, or otherwise released into the environment on or after July 2, 1979, where the concentration of the spill or release was ≥50 ppm, must dispose of it in accordance with either of the following:</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>8. Amend § 761.60 by revising paragraphs (b)(2)(v)(C) and (g)(1)(iii) and (2)(ii) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.60</SECTNO>
                        <SUBJECT> Disposal requirements.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(2) * * *</P>
                        <P>(v) * * *</P>
                        <P>(C) There is other good cause shown. As part of this evaluation, the Assistant Administrator will consider the impact of their action on the incentives to construct or expand PCB incinerators.</P>
                        <STARS/>
                        <P>(g) * * *</P>
                        <P>(1) * * *</P>
                        <P>(iii) Unless otherwise specified in this part, any person conducting the chemical analysis of PCBs shall do so using gas chromatography. Any gas chromatographic method that is appropriate for the material being analyzed may be used, including EPA Method 608.3, 40 CFR part 136, Appendix A; EPA Method 8082A (incorporated by reference, see § 761.19) and ASTM D4059-00 (incorporated by reference, see § 761.19).</P>
                        <P>(2) * * *</P>
                        <P>
                            (ii) For purposes of complying with the marking and disposal requirements, representative samples may be taken from either the common containers or the individual electrical equipment to 
                            <PRTPAGE P="58754"/>
                            determine the PCB concentration. Except, that if any PCBs at a concentration of 500 ppm or greater have been added to the container or equipment then the total container contents must be considered as having a PCB concentration of 500 ppm or greater for purposes of complying with the disposal requirements of this subpart. For purposes of this paragraph, representative samples of mineral oil dielectric fluid are either samples taken in accordance with ASTM D 923-86 or ASTM D 923-89 (both incorporated by reference, see § 761.19) or samples taken from a container that has been thoroughly mixed in a manner such that any PCBs in the container are uniformly distributed throughout the liquid in the container.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>
                        9. Amend § 761.61 by revising paragraphs (a)(3)(ii) (5)(i)(B)(
                        <E T="03">2</E>
                        )(
                        <E T="03">iv</E>
                        ), and (7), the introductory text to paragraph (a)(8), paragraphs (a)(8)(i)(A) and (B), paragraph (b), the subject heading to paragraph (c), and (c)(1) to read as follows:
                    </AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.61</SECTNO>
                        <SUBJECT> PCB remediation waste.</SUBJECT>
                        <STARS/>
                        <P>(a) * * *</P>
                        <P>(3) * * *</P>
                        <P>(ii) Within 30 calendar days of receiving the notification, the EPA Regional Administrator will respond in writing approving of the self-implementing cleanup, disapproving of the self-implementing cleanup, or requiring additional information. If the EPA Regional Administrator does not respond within 30 calendar days of receiving the notice, the person submitting the notification may proceed with the cleanup according to the information the person provided to the EPA Regional Administrator. If, upon review of the notification, the EPA Regional Administrator determines that the notification does not contain all of the information required by paragraph (a)(3)(i) of this section, sufficient to ensure compliance with paragraphs (a)(4) through (9) of this section at the site, they may require the submission of additional information. The cleanup and disposal must comply with all applicable requirements of paragraphs (a)(4) through (9) of this section. Once cleanup is underway, the person conducting the cleanup must provide any proposed changes from the notification to the EPA Regional Administrator in writing no less than 14 calendar days prior to the proposed implementation of the change. The EPA Regional Administrator will determine in their discretion whether to accept the change, and will respond to the change notification verbally within 7 calendar days and in writing within 14 calendar days of receiving it. If the EPA Regional Administrator does not respond verbally within 7 calendar days and in writing within 14 calendar days of receiving the change notice, the person who submitted it may proceed with the cleanup according to the information in the change notice provided to the EPA Regional Administrator, subject to the submission of additional information if the Regional Administrator determines it is needed to address the elements of paragraph (a)(3)(i) of this section, and in compliance with all applicable requirements of paragraphs (a)(4) through (9) of this section and other applicable requirements of this part.</P>
                        <STARS/>
                        <P>(5) * * *</P>
                        <P>(i) * * *</P>
                        <P>(B) * * *</P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) * * *
                        </P>
                        <P>
                            (
                            <E T="03">iv</E>
                            ) The generator must provide written notice, including the quantity to be shipped and highest concentration of PCBs at least 15 days before the first shipment of bulk PCB remediation waste from each cleanup site by the generator, to each off-site facility where the waste is destined for an area not subject to a TSCA PCB Disposal Approval. The generator must select applicable method(s) from the following list to extract PCBs and determine the PCB concentration from individual and composite samples of PCB remediation waste: SW-846 Method 3510C, Method 3520C, Method 3535A, Method 3540C, Method 3541, Method 3545A, Method 3546, Method 8082, Method 8082A, Method 8275A, or CWA Method 1668C (all incorporated by reference, see § 761.19). Modifications to the methods listed in this paragraph or alternative methods not listed may be used if validated under subpart Q of this part or authorized in a § 761.61(c) approval.
                        </P>
                        <STARS/>
                        <P>
                            (7) 
                            <E T="03">Cap requirements.</E>
                             A cap means, when referring to on-site cleanup and disposal of PCB remediation waste, a uniform placement of concrete, asphalt, or similar material of minimum thickness spread over the area where remediation waste was removed or left in place in order to prevent or minimize human exposure, infiltration of water, and erosion. Any person designing and constructing a cap must do so in accordance with § 264.310(a) of this chapter, and ensure that it complies with the permeability, sieve, liquid limit, and plasticity index parameters in § 761.75(b)(1)(ii) through (b)(1)(v). A cap of compacted soil shall have a minimum thickness of 25 cm (10 inches). A concrete or asphalt cap shall have a minimum thickness of 15 cm (6 inches). A cap must be of sufficient strength to maintain its effectiveness and integrity during the use of the cap surface which is exposed to the environment. A cap shall not be contaminated at a level ≥1 ppm PCB. Repairs shall begin within 72 hours of discovery for any breaches which would impair the integrity of the cap.
                        </P>
                        <P>
                            (8) 
                            <E T="03">Deed restrictions for caps, fences and low occupancy areas.</E>
                             When a cleanup activity conducted under this section includes the use of a fence or a cap, the owner of the site must maintain the fence or cap, in perpetuity. In addition, whenever a fence, a cap, or the procedures and requirements for a low occupancy area, is used, the owner of the site must meet the following conditions:
                        </P>
                        <P>(i) * * *</P>
                        <P>(A) Record, in accordance with State law, a notation on the deed to the property, or on some other instrument which is normally examined during a title search, that will in perpetuity notify any potential purchaser of the property:</P>
                        <P>(1) That the land, or the specific portion thereof identified in the instrument when only a portion is subject to the instrument, has been used for PCB remediation waste disposal and, when applicable, that the area is restricted to use as a low occupancy area as defined in § 761.3;</P>
                        <P>(2) Of the existence of the fence or cap and the requirement to maintain the fence or cap, when applicable; and</P>
                        <P>(3) The applicable cleanup levels left at the site, including inside any fence, and/or under any cap, or in a low occupancy area.</P>
                        <P>(B) Submit a certification, signed by the owner, that they have recorded the notation specified in paragraph (a)(8)(i)(A) of this section to the EPA Regional Administrator.</P>
                        <P>(ii) The owner of a site being cleaned up under this section may remove a fence, cap, or low occupancy designation after conducting additional cleanup activities and achieving cleanup levels, specified in paragraph (a)(4) of this section, which do not require a fence, cap, or low occupancy designation. The owner may remove the notice on the deed no earlier than 30 days after achieving the cleanup levels specified in this section which do not require a fence, cap, or low occupancy designation.</P>
                        <STARS/>
                        <P>
                            (b) 
                            <E T="03">Performance-based cleanup and disposal.</E>
                             Any person may clean up and dispose of PCB remediation waste at a 
                            <PRTPAGE P="58755"/>
                            site in full compliance with the performance-based cleanup provisions of paragraph (b)(1) of this section and disposal provisions of paragraph (b)(2) of this section. Alternatively, any person may dispose of PCB remediation waste in accordance with paragraph (b)(2) of this section, but such disposal does not relieve the site owner of cleanup and disposal obligations for any PCBs that remain on-site if the provisions of paragraph (b)(1) of this section are not complied with.
                        </P>
                        <P>
                            (1) 
                            <E T="03">Performance-based cleanup of PCB remediation waste.</E>
                        </P>
                        <P>
                            (i) 
                            <E T="03">Applicability.</E>
                             (A) The performance-based cleanup option may not be used to clean up:
                        </P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Surface or ground waters.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Sediments in marine and freshwater ecosystems.
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) Sewers or sewage treatment systems.
                        </P>
                        <P>
                            (
                            <E T="03">4</E>
                            ) Any private or public drinking water sources or distribution systems.
                        </P>
                        <P>
                            (
                            <E T="03">5</E>
                            ) Grazing or agricultural lands.
                        </P>
                        <P>
                            (
                            <E T="03">6</E>
                            ) Vegetable gardens.
                        </P>
                        <P>
                            (
                            <E T="03">7</E>
                            ) Sites which are adjacent to, contain, or are proposed to be redeveloped to contain: Residential dwellings, hospitals, schools, nursing homes, playgrounds, parks, day care centers, endangered species habitats, estuaries, wetlands, national parks, national wildlife refuges, commercial fisheries, sport fisheries, or surface waters.
                        </P>
                        <P>
                            (
                            <E T="03">8</E>
                            ) Sites where the PCB contamination is in the 100-year floodplain.
                        </P>
                        <P>(B) The performance-based cleanup provisions shall not be binding upon cleanups conducted under other authorities, including but not limited to, actions conducted under section 104 or section 106 of CERCLA, or section 3004(u) and (v) or section 3008(h) of RCRA.</P>
                        <P>
                            (ii) 
                            <E T="03">Cleanup level.</E>
                             All on-site PCB remediation waste above the following cleanup levels must be disposed of or decontaminated in accordance with paragraph (b)(2) of this section.
                        </P>
                        <P>(A) The cleanup level for bulk PCB remediation waste and porous surfaces is ≤1 ppm PCBs.</P>
                        <P>(B) The cleanup levels for liquids are the concentrations specified in §§ 761.79(b)(1) and (b)(2).</P>
                        <P>(C) The cleanup levels for nonporous surfaces are the concentrations specified in § 761.79(b)(3).</P>
                        <P>
                            (iii) 
                            <E T="03">Verification sampling.</E>
                             Verification sampling for bulk PCB remediation waste and porous surfaces must be conducted in accordance with Subpart O. Verification sampling for nonporous surfaces must be conducted in accordance with Subpart P. Verification sampling for liquid PCB remediation waste must be conducted in accordance with § 761.269. When analysis of each sample results in a measurement of PCBs less than or equal to the levels specified in paragraph (b)(1)(ii) of this section, on-site performance-based cleanup is complete.
                        </P>
                        <P>
                            (iv) 
                            <E T="03">Recordkeeping.</E>
                             Recordkeeping is required in accordance with § 761.125(c)(5).
                        </P>
                        <P>
                            (v) 
                            <E T="03">Cleanup Completion Notification.</E>
                             Within 14 days of sending the final shipment of waste offsite for disposal from a site cleaned up under this paragraph, the person in charge of the cleanup or the owner of the property where the PCB remediation waste was located shall notify, in writing, the EPA Regional Administrator, the Director of the State or Tribal environmental protection agency, and the Director of the county or local environmental protection agency where the cleanup was conducted. EPA may require additional on-site cleanup upon finding that the cleanup level(s) in (b)(1)(ii) of this section have not been met. Upon review of the cleanup completion notification, EPA may request that the responsible party submit additional information related to the records required under (b)(1)(iv) of this section to clarify that the cleanup has been completed in accordance with the requirements of this section. The notification shall include:
                        </P>
                        <P>(A) Site identification information, including the site address and the name, phone number, and email address of the site contact;</P>
                        <P>(B) Disposal facility and shipment information, including the disposal facility's name and address, the manifest tracking number(s), and the quantity of waste shipped;</P>
                        <P>(C) A summary of all applicable components of the records in § 761.125(c)(5); and</P>
                        <P>(D) A certification using the language in § 761.3.</P>
                        <P>
                            (2) 
                            <E T="03">Performance-based disposal.</E>
                        </P>
                        <P>(i) Any person disposing of liquid PCB remediation waste under this subsection shall do so according to § 761.60(a) or (e), or decontaminate it in accordance with § 761.79.</P>
                        <P>(ii) Any person disposing of non-liquid PCB remediation waste under this subsection shall do so by one of the following methods:</P>
                        <P>(A) Dispose of it in a high temperature incinerator approved under § 761.70(b), an alternate disposal method approved under § 761.60(e), a chemical waste landfill approved under § 761.75, a facility with a coordinated approval issued under § 761.77, or a hazardous waste landfill permitted by EPA under section 3005 of RCRA, or by a state authorized under section 3006 of RCRA.</P>
                        <P>(B) Decontaminate it in accordance with § 761.79.</P>
                        <P>(iii) Any person may manage or dispose of material containing &lt;50 ppm PCBs that has been dredged or excavated from waters of the United States:</P>
                        <P>(A) In accordance with a permit that has been issued under section 404 of the Clean Water Act, or the equivalent of such a permit as provided for in regulations of the U.S. Army Corps of Engineers at 33 CFR part 320.</P>
                        <P>(B) In accordance with a permit issued by the U.S. Army Corps of Engineers under section 103 of the Marine Protection, Research, and Sanctuaries Act, or the equivalent of such a permit as provided for in regulations of the U.S. Army Corps of Engineers at 33 CFR part 320.</P>
                        <P>
                            (c) 
                            <E T="03">Risk-based cleanup and disposal approval.</E>
                             (1) Any person wishing to sample, extract, analyze, cleanup, or dispose of PCB remediation waste in a manner other than prescribed in paragraphs (a) or (b) of this section, or store PCB remediation waste in a manner other than prescribed in § 761.65, must apply in writing to the Regional Administrator in the Region where the sampling, extraction, analysis, cleanup, disposal, or storage site is located, for sampling, extraction, analysis, cleanup, disposal, or storage occurring in a single EPA Region; or to the Director, Office of Resource Conservation and Recovery, for sampling, extraction, analysis, cleanup, disposal, or storage occurring in more than one EPA Region. Each application must include information described in the notification required by paragraph (a)(3) of this section. EPA may request other information that it believes necessary to evaluate the application. No person may conduct cleanup activities under this paragraph prior to obtaining written approval by EPA.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>10. Amend § 761.62 by revising paragraphs (c)(1) and (d) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.62</SECTNO>
                        <SUBJECT> Disposal of PCB bulk product waste.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>
                            (1) Any person wishing to sample, extract, analyze, or dispose of PCB bulk product waste in a manner other than prescribed in paragraphs (a) or (b) of this section, or store PCB bulk product waste in a manner other than prescribed in § 761.65, must apply in writing to the Regional Administrator in the Region where the sampling, extraction, 
                            <PRTPAGE P="58756"/>
                            analysis, disposal, or storage site is located, for sampling, extraction, analysis, disposal, or storage occurring in a single EPA Region; or to the Director, Office of Resource Conservation and Recovery, for sampling, extraction, analysis, disposal, or storage occurring in more than one EPA Region. Each application must contain information indicating that, based on technical, environmental, or waste-specific characteristics or considerations, the proposed sampling, extraction, analysis, disposal, or storage methods or locations will not pose an unreasonable risk or injury to health or the environment. EPA may request other information that it believes necessary to evaluate the application. No person may conduct sampling, extraction, analysis, disposal, or storage activities under this paragraph prior to obtaining written approval by EPA.
                        </P>
                        <STARS/>
                        <P>
                            (d) 
                            <E T="03">Disposal as daily landfill cover.</E>
                             Bulk product waste described in paragraph (b)(1) of this section may be disposed of as daily landfill cover as long as the daily cover remains in the landfill and is not released or dispersed by wind or other action.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>11. Amend § 761.65 by revising paragraphs (c)(9)(i) and (9)(iii) (A) and (B), and introductory paragraphs (g) and (g)(1), (1)(iv), (2), (3)(i), (4)(i) and (5), (6) and (7), and introductory paragraph (h) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.65</SECTNO>
                        <SUBJECT> Storage for disposal.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(9) * * *</P>
                        <P>(i) The waste is placed in a pile or non-leaking, covered container designed and operated to control dispersal of the waste by wind, where necessary, by means other than wetting.</P>
                        <STARS/>
                        <P>(iii) The storage site must have:</P>
                        <P>(A) A liner or container that is designed, constructed, and installed to prevent any migration of wastes off or through the liner or container into the adjacent subsurface soil, ground water or surface water at any time during the active life (including the closure period) of the storage site. The liner or container may be constructed of materials that may allow waste to migrate into the liner or container. The liner or container must be:</P>
                        <P>(1) Constructed of materials that have appropriate chemical properties and sufficient strength and thickness to prevent failure due to pressure gradients (including static head and external hydrogeologic forces), physical contact with the waste or leachate to which they are exposed, climatic conditions, the stress of installation, and the stress of daily operation.</P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Placed upon a foundation or base capable of providing support to the liner or container and resistance to pressure gradients above and below the liner to prevent failure of the liner due to settlement, compression, or uplift.
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) In the case of liners, installed to cover all surrounding earth likely to be in contact with the waste.
                        </P>
                        <P>(B) A cover that meets the requirements of paragraph (c)(9)(iii)(A) of this section, is installed to cover all of the stored waste likely to be in contact with precipitation, and is secured so as not to be functionally disabled by winds expected under normal seasonal meteorological conditions at the storage site.</P>
                        <STARS/>
                        <P>
                            (g) 
                            <E T="03">Financial assurance for closure.</E>
                             A commercial storer of PCB waste shall establish financial assurance for closure of each PCB storage facility that they own or operate. In establishing financial assurance for closure, the commercial storer of PCB waste may choose from the following financial assurance mechanisms or any combination of mechanisms:
                        </P>
                        <P>(1) The “closure trust fund,” as specified in § 264.143(a) of this chapter, except for paragraph (a)(3) of § 264.143 and except when the Regional Administrator specifies modifications for the purposes of implementation under TSCA. For purposes of this paragraph, the following provisions also apply:</P>
                        <STARS/>
                        <P>(iv) The submission of a trust agreement with the wording specified in § 264.151(a)(1) of this chapter, including any reference to hazardous waste management facilities, shall be deemed to be in compliance with the requirement to submit a trust agreement under this subpart except when the Regional Administrator specifies modifications for the purposes of implementation under TSCA.</P>
                        <P>(2) The “surety bond guaranteeing payment into a closure trust fund,” as specified in § 264.143(b) of this chapter, including the use of the surety bond instrument specified at § 264.151(b) of this chapter and the standby trust specified at § 264.143(b)(3) of this chapter except when the Regional Administrator specifies modifications for the purposes of implementation under TSCA. The use of the surety bonds, surety bond instruments, and standby trust agreements specified in §§ 264.143(b) and 264.151(b) of this chapter, with any modifications specified by the Regional Administrator, shall be deemed to be in compliance with this subpart.</P>
                        <P>(3)(i) The “surety bond guaranteeing performance of closure,” as specified at § 264.143(c) of this chapter, except for paragraph (c)(5) of § 264.143 of this chapter and except when the Regional Administrator specifies modifications for the purposes of implementation under TSCA. The submission and use of the surety bond instrument specified at § 264.151(c) of this chapter and the standby trust specified at § 264.143(c)(3) of this chapter, with any modifications specified by the Regional Administrator, shall be deemed to be in compliance with the requirements under this subpart relating to the use of surety bonds and standby trust funds.</P>
                        <STARS/>
                        <P>(4)(i) The “closure letter of credit” specified in § 264.143(d) of this chapter, except for paragraph (d)(8) and except when the Regional Administrator specifies modifications for the purposes of implementation under TSCA. The submission and use of the irrevocable letter of credit instrument specified in § 264.151(d) of this chapter and the standby trust specified in § 264.143(d)(3) of this chapter, with any modifications specified by the Regional Administrator, shall be deemed to be in compliance with the requirements of this subpart relating to the use of letters of credit and standby trust funds.</P>
                        <STARS/>
                        <P>(5) “Closure insurance,” as specified in § 264.143(e) of this chapter, utilizing the certificate of insurance for closure specified at § 264.151(e) of this chapter except when the Regional Administrator specifies modifications for the purposes of implementation under TSCA. The use of closure insurance as specified in § 264.143(e) of this chapter and the submission and use of the certificate of insurance specified in § 264.151(e) of this chapter, with any modifications specified by the Regional Administrator, shall be deemed to be in compliance with the requirements of this subpart relating to the use of closure insurance.</P>
                        <P>
                            (6) The “financial test and corporate guarantee for closure,” as described in § 264.143(f) of this chapter except when the Regional Administrator specifies modifications for the purposes of implementation under TSCA, including a letter signed by the owner's or operator's chief financial officer as specified at § 264.151(f) of this chapter and, if applicable, the written corporate guarantee specified at § 264.151(h) of this chapter. The use of the financial test and corporate guarantee specified in 
                            <PRTPAGE P="58757"/>
                            § 264.143(f) of this chapter, the submission and use of the letter specified in § 264.151(f) of this chapter, and the submission and use of the written corporate guarantee specified at § 264.151(h) of this chapter, with any modifications specified by the Regional Administrator, shall be deemed to be in compliance with the requirements of this subpart relating to the use of financial tests and corporate guarantees.
                        </P>
                        <P>(7) The corporate guarantee as specified in § 264.143(f)(10) of this chapter except when the Regional Administrator specifies modifications for the purposes of implementation under TSCA.</P>
                        <STARS/>
                        <P>
                            (h) 
                            <E T="03">Release of owner or operator.</E>
                             Within 60 days after receiving certifications from the owner or operator and an independent registered professional engineer that final closure has been completed in accordance with the approved closure plan, EPA will notify the owner or operator in writing that the owner or operator is no longer required by this section to maintain financial assurance for final closure of the facility, unless EPA has reason to believe that final closure has not been completed in accordance with the approved closure plan. EPA shall provide the owner or operator with a detailed written statement stating the reasons why EPA believed closure was not conducted in accordance with the approved closure plan.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>12. Add § 761.66 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.66</SECTNO>
                        <SUBJECT> Emergency situations</SUBJECT>
                        <P>This section establishes procedures that may be used for purposes of the cleanup and/or disposal of PCB waste resulting from PCB releases caused by an emergency situation as defined in § 761.3. This section allows the request of a waiver of any of the requirements in §§ 761.60, 761.61, 761.62, or 761.65. This section does not prohibit any person from implementing temporary emergency measures to prevent, treat, or contain further releases or mitigate migration to the environment of PCBs or PCB remediation waste.</P>
                        <P>
                            (a) 
                            <E T="03">Applicability.</E>
                             This section may only be applied to the cleanup and/or disposal of PCB waste directly resulting from PCB releases that are caused by an emergency situation as defined in § 761.3.
                        </P>
                        <P>
                            (b) 
                            <E T="03">Waiver Request.</E>
                             Any person intending or planning to sample, extract, analyze, clean up, store, and/or dispose of PCBs under this section shall submit a waiver request to the Regional Administrator in the EPA Region where the sampling, extraction, analysis, cleanup, storage, and/or disposal is, or will be, located, in writing and/or by email no later than seven (7) days after discovery of the release or implementation of any temporary emergency measures, as applicable. If the sampling, extraction, analysis, cleanup, storage, or disposal activities in the waiver request would be conducted in more than one Region, then the waiver request must be submitted, in its entirety, to the Regional Administrators for all affected Regions.
                        </P>
                        <P>(1) This request shall include:</P>
                        <P>(i) The contact information for the person requesting the waiver.</P>
                        <P>(ii) Location(s) of the release(s).</P>
                        <P>(iii) A description of the emergency situation and the adverse conditions caused by the emergency situation.</P>
                        <P>(iv) The type(s) of material(s) that are contaminated and the source of the release, if known.</P>
                        <P>(v) The as-found PCB concentrations in the PCB waste, unless the materials are being managed as if they contain ≥500 ppm PCBs. If actual PCB concentrations have not yet been determined, then estimated concentrations may be provided in the request. Actual PCB concentrations shall be determined before disposal activities commence, unless the waste is being managed as if it contains ≥500 ppm PCBs.</P>
                        <P>(vi) The provisions of §§ 761.60, 761.61, 761.62, or 761.65 that the person requests to waive or modify (or to use alternative procedures for) and an explanation of why compliance with the existing provisions would be impracticable as a result of the emergency situation.</P>
                        <P>(vii) The plan for how sampling, extraction, analysis, storage, cleanup, and/or disposal of the PCB waste would be conducted if the relief described in paragraph (b)(v) of this section were granted. The plan shall provide information to support how the actions described in the plan do not pose an unreasonable risk of injury to health or the environment. This plan shall be based on the as-found PCB concentrations in the materials unless waste is being managed as if it contained PCBs ≥500 ppm.</P>
                        <P>(viii) Whether or not the PCB waste is near, or likely to impact, surface waters, ground waters, drinking water sources or distribution systems, wells, sediments, sewers or sewage treatment systems, grazing lands, vegetable gardens, residential dwellings, hospitals, schools, nursing homes, playgrounds, parks, day care centers, endangered species habitats, estuaries, wetlands, national parks, national wildlife refuges, commercial fisheries, or sport fisheries and how those areas and potential impacts will be addressed.</P>
                        <P>(2) To make changes to submitted information described in (b)(1) of this section, the requestor shall submit the new information to the EPA Regional Administrator(s) in writing and/or by email.</P>
                        <P>
                            (c) 
                            <E T="03">Approval of waiver requests.</E>
                             The EPA Regional Administrator may approve the waiver request, request additional information, approve the waiver request with specified changes or additional conditions, or deny the waiver request, in writing, by telephone, or by email. An approval, with or without changes or conditions, shall be based on the Regional Administrator's finding that compliance with the regulatory requirements from which a waiver is sought is impracticable and that the action approved under the waiver will not pose an unreasonable risk of injury to health or the environment. At any point, EPA may require additional sampling, extraction, analysis, cleanup, storage, and/or disposal requirements, or require the requestor to delay acting on their proposed plan, in order to ensure the actions will not pose an unreasonable risk of injury to health or the environment.
                        </P>
                        <P>(d) Sampling, extraction, analysis, cleanup, storage, and disposal activities as described in the waiver request may begin after the EPA Regional Administrator responds with approval of the waiver request. All sampling, extraction, analysis, cleanup, storage, and disposal activities shall be conducted in compliance with the terms of the approval and all applicable provisions §§ 761.60, 761.61, 761.62, and 761.65 not expressly waived by the approval.</P>
                        <P>(e) Sampling, extraction, analysis, cleanup, storage, and disposal activities conducted under this section shall be based on the as-found concentration of the PCB waste unless the materials are being managed as if they contain ≥500 ppm PCBs.</P>
                        <P>
                            (f) 
                            <E T="03">Records, manifests, and certification.</E>
                             Recordkeeping and certification are required in accordance with § 761.125(c)(5). The manifesting and reporting requirements in Subpart K apply to waste disposed of under this section. However, if the person requesting a waiver has not previously submitted a notification of PCB activity as described in § 761.205 and the requirements of § 761.205 specify that such notification is required for the cleanup, storage, and/or disposal activity, the requestor shall submit the 
                            <PRTPAGE P="58758"/>
                            notification within ten (10) business days of their waiver request. The requestor does not have to wait to obtain their EPA identification number before initiating cleanup and/or disposal activities described in their approved waiver request. While waiting for their identification number, the requestor may use the generic identification “40 CFR part 761” in lieu of an EPA identification number on manifests for PCB waste. The requestor may alternatively use an EPA identification number they previously obtained from EPA under RCRA or a state under an authorized RCRA program, if they have one. Once the requestor receives an EPA identification number, they shall use it on manifests for PCB waste.
                        </P>
                    </SECTION>
                    <AMDPAR>13. Amend § 761.70 by revising paragraph (d)(4)(i) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.70</SECTNO>
                        <SUBJECT> Incineration.</SUBJECT>
                        <STARS/>
                        <P>(d) * * *</P>
                        <P>(4) * * *</P>
                        <P>(i) Except as provided in paragraph (d)(5) of this section, the Regional Administrator or the appropriate official at EPA Headquarters may not approve an incinerator for the disposal of PCBs and PCB Items unless they find that the incinerator meets all of the requirements of paragraphs (a) and/or (b) of this section.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>14. Amend § 761.71 by revising paragraph (b)(2)(iv) and (vi) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.71</SECTNO>
                        <SUBJECT> High efficiency boilers.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(2) * * *</P>
                        <P>(iv) The type of equipment, apparatus, and procedures to be used to control the feed of PCB liquids to the boiler and to monitor and record the carbon monoxide concentration and excess oxygen percentage in the stack.</P>
                        <STARS/>
                        <P>(vi) The concentration of PCBs and of any other chlorinated hydrocarbon in the waste and the results of analyses using the ASTM International methods as follows: Carbon and hydrogen content using ASTM D5373-16, nitrogen content using ASTM E258-67 (Reapproved 1987) or ASTM D5373-16, sulfur content using ASTM D1266-87, or ASTM D129-64 (Reapproved 1978), chlorine content using ASTM D808-87, water and sediment content using either ASTM D2709-88 or ASTM D1796-83 (Reapproved 1990), ash content using ASTM D482-13, calorific value using ASTM D240-87, carbon residue using either ASTM D2158-89 or ASTM D524-88, and flash point using ASTM D93-09, ASTM D8174-18, ASTM D8175-18, or ASTM D3278-96 (all incorporated by reference, see § 761.19).</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>15. Amend § 761.75 by revising paragraphs (b)(8)(iii) and (c)(3)(i) and (4) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.75</SECTNO>
                        <SUBJECT> Chemical waste landfills.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(8) * * *</P>
                        <P>(iii) Ignitable wastes shall not be disposed of in chemical waste landfills. Liquid ignitable wastes are wastes that have a flash point less than 60 degrees C (140 degrees F) as determined by the following method or an equivalent method: Flash point of liquids shall be determined by a Pensky-Martens Closed Cup Tester, using the protocol specified in ASTM D93-09 or ASTM D8175-18, or a Small Scale Closed Cup Tester, using the protocol specified in ASTM D3278-96 (Reapproved 2011) or ASTM D8174-18 (all incorporated by reference, § 761.19).</P>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(3) * * *</P>
                        <P>(i) Except as provided in paragraph (c)(4) of this section the Regional Administrator may not approve a chemical waste landfill for the disposal of PCBs and PCB Items, unless they find that the landfill meets all of the requirements of paragraph (b) of this section.</P>
                        <STARS/>
                        <P>
                            (4) 
                            <E T="03">Waivers.</E>
                             An owner or operator of a chemical waste landfill may submit evidence to the Regional Administrator that operation of the landfill will not present an unreasonable risk of injury to health or the environment from PCBs when one or more of the requirements of paragraph (b) of this section are not met. On the basis of such evidence and any other available information, the Regional Administrator may in their discretion find that one or more of the requirements of paragraph (b) of this section is not necessary to protect against such a risk and may waive the requirements in any approval for that landfill. Any finding and waiver under this paragraph will be stated in writing and included as part of the approval.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>16. Amend § 761.77 by revising paragraphs (a)(1)(ii)(B), introductory paragraph (a)(2), and introductory paragraph (b) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.77</SECTNO>
                        <SUBJECT> Coordinated approval.</SUBJECT>
                        <STARS/>
                        <P>(a) * * *</P>
                        <P>(1) * * *</P>
                        <P>(ii) * * *</P>
                        <P>(B) Issue a letter granting or denying the TSCA PCB Coordinated Approval. If the EPA Regional Administrator grants the TSCA PCB Coordinated Approval, they may acknowledge the non-TSCA approval meets the regulatory requirements under TSCA as written, or require additional conditions the EPA Regional Administrator has determined are necessary to prevent unreasonable risk of injury to health or the environment.</P>
                        <STARS/>
                        <P>(2) The EPA Regional Administrator may issue a notice of deficiency, revoke the TSCA PCB Coordinated Approval, require the person to whom the TSCA PCB Coordinated Approval was issued to submit an application for a TSCA PCB approval, or bring an enforcement action under TSCA if they determine that:</P>
                        <STARS/>
                        <P>(b) Any person who owns or operates a facility that they intend to use to landfill PCB wastes; incinerate PCB wastes; dispose of PCB wastes using an alternative disposal method that is equivalent to disposal in an incinerator approved under § 761.70 or a high efficiency boiler operating in compliance with § 761.71; or stores PCB wastes may apply for a TSCA PCB Coordinated Approval. The EPA Regional Administrator may approve the request if the EPA Regional Administrator determines that the activity will not pose an unreasonable risk of injury to health or the environment and the person:</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>17. Amend § 761.79 by revising paragraph (h)(3) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.79</SECTNO>
                        <SUBJECT> Decontamination standards and procedures.</SUBJECT>
                        <STARS/>
                        <P>(h) * * *</P>
                        <P>
                            (3) Any person wishing to sample, extract, or analyze decontaminated material in a manner other than prescribed in paragraph (f) of this section must apply in writing to the Regional Administrator in the Region where the activity would take place, for decontamination activity occurring in a single EPA Region; or to the Director, Office of Resource Conservation and Recovery, for decontamination activity occurring in more than one EPA Region. Each application must contain a description of the material to be decontaminated, the nature and PCB concentration of the contaminating material (if known), the decontamination method, the proposed extraction, analysis, and/or sampling 
                            <PRTPAGE P="58759"/>
                            procedure, and a justification for how the proposed extraction, analysis, and/or sampling is equivalent to or more comprehensive than the extraction, analysis, and/or sampling procedure required under paragraph (f) of this section.
                        </P>
                        <STARS/>
                    </SECTION>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart G—PCB Spill Cleanup Policy</HD>
                    </SUBPART>
                    <AMDPAR>18. Amend § 761.120 by revising paragraphs (b)(2) and (c) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.120</SECTNO>
                        <SUBJECT> Scope.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(2) In those situations, the Regional Administrator may require cleanup in addition to that required under § 761.125(b) and (c). However, the Regional Administrator must first make a finding, based on the specific facts of a spill, that additional cleanup is necessary to prevent unreasonable risk. In addition, before making a final decision on additional cleanup, the Regional Administrator must notify the Director, Office of Resource Conservation and Recovery of their finding and the basis for the finding.</P>
                        <STARS/>
                        <P>
                            (c) 
                            <E T="03">Flexibility to allow less stringent or alternative requirements.</E>
                             (1) EPA retains the flexibility to allow less stringent or alternative decontamination measures based upon site-specific considerations. EPA will exercise this flexibility if the responsible party demonstrates that cleanup to the numerical decontamination levels is clearly unwarranted because of risk-mitigating factors, that compliance with the procedural requirements or numerical standards in the policy is impracticable at a particular site, or that site-specific characteristics make the costs of cleanup prohibitive. The Regional Administrator will notify the Director, Office of Resource Conservation and Recovery of any decision and the basis for the decision to allow less stringent cleanup. The purpose of this notification is to enable the Director, Office of Resource Conservation and Recovery to ensure consistency of spill cleanup standards under special circumstances across the regions.
                        </P>
                        <P>(2) In emergency situations, as defined in § 761.123, the following provisions of this Policy are hereby modified as follows:</P>
                        <P>(i) For actions taken directly in response to spills caused by emergency situations, responsible parties may use the as-found concentrations in the spill materials when determining whether to manage the spill under § 761.125(b) or (c) of this Policy when it is not possible to readily determine the spill source concentration at a site.</P>
                        <P>(ii) For spills caused by emergency situations, the applicable notifications in § 761.125(a)(1) must be submitted as soon as possible, but no later than seven (7) days after the adverse conditions that prevented notification have ended.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>19. Amend § 761.123 by:</AMDPAR>
                    <AMDPAR>a. Adding the definition “Emergency situation” in alphabetical order ; and</AMDPAR>
                    <AMDPAR>b. Revising the definitions “Other restricted access (nonsubstation) locations” and “Spill”.</AMDPAR>
                    <P>The revisions and additions read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 761.123</SECTNO>
                        <SUBJECT> Definitions.</SUBJECT>
                        <STARS/>
                        <P>
                            <E T="03">Emergency situation</E>
                             means adverse conditions caused by manmade or natural incidents that threaten lives, property, or public health and safety; require prompt responsive action from the local, state, tribal, territorial, or federal government; and result in: (1) A declaration by either the President of the United States or Governor of the affected state of a natural disaster or emergency; or, (2) an incident funded under FEMA via a Stafford Act disaster declaration or emergency declaration. Examples of emergency situations may include civil emergencies or adverse natural conditions, such as hurricanes, earthquakes, or tornados.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Other restricted access (nonsubstation) locations</E>
                             means areas other than electrical substations that are at least 0.1 kilometer (km) from a residential/commercial area and limited by man-made barriers (
                            <E T="03">e.g.,</E>
                             fences and walls) or substantially limited by naturally occurring barriers such as mountains, cliffs, or rough terrain. These areas generally include industrial facilities and extremely remote rural locations. (Areas where access is restricted but are less than 0.1 km from a residential/commercial area are considered to be residential/commercial areas.)
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Spill</E>
                             means both intentional and unintentional spills, leaks, and other uncontrolled discharges where the release results in any quantity of PCBs running off or about to run off the external surface of the equipment or other PCB source, as well as the contamination resulting from those releases. This policy applies to spills of 50 ppm or greater PCBs. The concentration of PCBs spilled is determined by the PCB concentration in the material spilled as opposed to the concentration of PCBs in the material onto which the PCBs were spilled, except where authorized in § 761.120(c). Where a spill of untested mineral oil occurs, the oil is presumed to contain greater than 50 ppm, but less than 500 ppm PCBs and is subject to the relevant requirements of this policy.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>20. Amend § 761.125 by revising paragraphs (a)(2), (c)(3)(iii), and (4)(iv) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.125</SECTNO>
                        <SUBJECT> Requirements for PCB spill cleanup.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>
                            (2) 
                            <E T="03">Disposal of cleanup debris and materials.</E>
                             All concentrated soils, solvents, rags, and other materials resulting from the cleanup of PCBs under this policy shall be properly stored, labeled, and disposed of at a facility with a TSCA disposal approval issued under Subpart D of this part.
                        </P>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(3) * * *</P>
                        <P>
                            (iii) At the option of the responsible party, low-contact, indoor, nonimpervious surfaces will be cleaned either to 10 μg/100 cm
                            <SU>2</SU>
                             or to 100 μg/100 cm
                            <SU>2</SU>
                             and encapsulated. The Regional Administrator, however, retains the authority to disallow the encapsulation option for a particular spill situation upon finding that the uncertainties associated with that option pose special concerns at that site. That is, the Regional Administrator would not permit encapsulation if they determine that if the encapsulation failed the failure would create an imminent hazard at the site.
                        </P>
                        <STARS/>
                        <P>(4) * * *</P>
                        <P>
                            (iv) At the option of the responsible party, low-contact, outdoor, nonimpervious solid surfaces shall be either cleaned to 10 μg/100 cm
                            <SU>2</SU>
                             or cleaned to 100 μg/100 cm
                            <SU>2</SU>
                             and encapsulated. The Regional Administrator, however, retains the authority to disallow the encapsulation option for a particular spill situation upon finding that the uncertainties associated with that option pose special concerns at that site. That is, the Regional Administrator would not permit encapsulation if they determine that if the encapsulation failed the failure would create an imminent hazard at the site.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>21. Amend § 761.130 by revising paragraph (e) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.130</SECTNO>
                        <SUBJECT> Sampling requirements.</SUBJECT>
                        <STARS/>
                        <PRTPAGE P="58760"/>
                        <P>
                            (e) EPA recommends the use of a sampling scheme developed by the Midwest Research Institute (MRI) for use in enforcement inspections: “Verification of PCB Spill Cleanup by Sampling and Analysis.” Guidance for the use of this sampling scheme is available in the MRI report “Field Manual for Grid Sampling of PCB Spill Sites to Verify Cleanup.” Both the MRI sampling scheme and the guidance document are available on EPA's PCB website at 
                            <E T="03">https://www.epa.gov/pcbs,</E>
                             or from the Program Implementation and Information Division, Office of Resource Conservation and Recovery (5303P), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. The major advantage of this sampling scheme is that it is designed to characterize the degree of contamination within the entire sampling area with a high degree of confidence while using fewer samples than any other grid or random sampling scheme. This sampling scheme also allows some sites to be characterized on the basis of composite samples.
                        </P>
                        <STARS/>
                    </SECTION>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart J—General Records and Reports</HD>
                    </SUBPART>
                    <AMDPAR>22. Amend § 761.180 by:</AMDPAR>
                    <AMDPAR>a. Revising introductory paragraph (b)(3),</AMDPAR>
                    <AMDPAR>b. Reserving paragraph (b)(3)(ii); and</AMDPAR>
                    <AMDPAR>c. Revising paragraph (b)(4).</AMDPAR>
                    <P>The revisions read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 761.180</SECTNO>
                        <SUBJECT> Records and monitoring.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(3) The owner or operator of a PCB disposal facility (including an owner or operator who disposes of his/her own waste and does not receive or generate manifests) or a commercial storage facility shall submit an annual report using EPA Form XXXX-YY, which briefly summarizes the records and annual document log required to be maintained and prepared under paragraphs (b)(1) and (2) of this section to the Director, Office Resource Conservation and Recovery at the address listed on the form, by July 15 of each year, beginning with July 15, 1991. The first annual report submitted on July 15, 1991, shall be for the period starting February 5, 1990, and ending December 31, 1990. The annual report shall contain no confidential business information. The annual report shall consist of the information listed in paragraphs (b)(3)(i) through (vi) of this section.</P>
                        <STARS/>
                        <P>(ii) [Reserved]</P>
                        <STARS/>
                        <P>(4) Whenever a commercial storer of PCB waste accepts PCBs or PCB Items at their storage facility and transfers the PCB waste off-site to another facility for storage or disposal, the commercial storer of PCB waste shall initiate a manifest under subpart K of this part for the transfer of PCBs or PCB Items to the next storage or disposal facility.</P>
                        <STARS/>
                    </SECTION>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart K—PCB Waste Disposal Records and Reports</HD>
                    </SUBPART>
                    <AMDPAR>23. In § 761.205 revise paragraphs (a)(3) and (4)(v) and (d) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.205</SECTNO>
                        <SUBJECT> Notification of PCB waste activity (EPA Form 7710-53).</SUBJECT>
                        <P>(a) * * *</P>
                        <P>
                            (3) Any person required to notify EPA under this section shall file with EPA Form 7710-53. Copies of EPA Form 7710-53 are available on EPA's website at 
                            <E T="03">https://www.epa.gov/pcbs,</E>
                             or from the Program Implementation and Information Division, Office of Resource Conservation and Recovery (5303P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001 ATTN: PCB Notification. Descriptive information and instructions for filling in the form are included in paragraphs (a)(4)(i) through (vii) of this section.
                        </P>
                        <P>(4) * * *</P>
                        <P>(v) The facility's installation contact, telephone number, and email address.</P>
                        <P>* * *</P>
                        <P>(d) Persons required to notify under this section shall file EPA Form 7710-53 with EPA by mailing the form to the address listed on the form.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>24. Amend § 761.207 by:</AMDPAR>
                    <AMDPAR>a. Revising paragraph (a),</AMDPAR>
                    <AMDPAR>b. Adding paragraphs (a)(4) and (5); and</AMDPAR>
                    <AMDPAR>c. Revising the “Note 2 to Paragraph (a) and paragraph (c).</AMDPAR>
                    <P>The revisions and addition read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 761.207 </SECTNO>
                        <SUBJECT>The manifest—general requirements.</SUBJECT>
                        <P>(a) A generator who transports, or offers for transport PCB waste for commercial off-site storage or off-site disposal, and commercial storage or disposal facility who offers for transport a rejected load of PCB waste, must prepare a manifest on EPA Form 8700-22, and, if necessary, a continuation sheet. The generator shall specify:</P>
                        <P>(1) For each bulk load of PCBs, the identity of the PCB waste, the earliest date of removal from service for disposal, and the weight in kilograms of the PCB waste. (Item 14—Special Handling Instructions box)</P>
                        <P>(2) For each PCB transformer, the serial number if available, or other identification if there is no serial number; the date of removal from service for disposal; and weight in kilograms of the PCB waste in each PCB transformer. (Item 14—Special Handling Instructions box)</P>
                        <P>(3) For each PCB Large High or Low Voltage Capacitor, the serial number if available, or other identification if there is no serial number; the date of removal from service for disposal; and weight in kilograms of the PCB waste in each PCB Large High or Low Voltage Capacitor. (Item 14—Special Handling Instructions box)</P>
                        <P>
                            (4) For each PCB Article Container, the unique identifying number, type of PCB waste (
                            <E T="03">e.g.,</E>
                             small capacitors), earliest date of removal from service for disposal, and weight in kilograms of the PCB waste contained therein. (Item 14—Special Handling Instructions box)
                        </P>
                        <P>
                            (5) For each PCB Container, the unique identifying number, type of PCB waste (
                            <E T="03">e.g.,</E>
                             soil, debris, small capacitors), earliest date of removal from service for disposal, and weight in kilograms of the PCB waste contained therein. (Item 14—Special Handling Instructions box)
                        </P>
                        <STARS/>
                        <EXTRACT>
                            <NOTE>
                                <HD SOURCE="HED">Note 2 to Paragraph (A):</HD>
                                <P> PCB waste handlers should use the EPA Form 8700-22 instructions as a guide, but should defer to the Part 761 manifest regulations whenever there is any difference between the Part 761 requirements and the instructions. The differences should be minimal.</P>
                            </NOTE>
                        </EXTRACT>
                        <STARS/>
                        <P>(c) A generator may also designate on the manifest one alternate facility which is approved to handle their PCB waste in the event an emergency prevents delivery of the waste to the primary designated facility.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>25. Amend § 761.212 by revising introductory paragraph (a) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.212</SECTNO>
                        <SUBJECT> Transporter compliance with the manifest.</SUBJECT>
                        <P>(a) The transporter must deliver the entire quantity of PCB waste which they have accepted from a generator or a transporter to:</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>26. Amend § 761.213 by revising introductory paragraph (a)(2) and introductory paragraph (b) to read as follows:</AMDPAR>
                    <SECTION>
                        <PRTPAGE P="58761"/>
                        <SECTNO>§ 761.213</SECTNO>
                        <SUBJECT> Use of the manifest-Commercial storage and disposal facility requirements.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>(2) If a commercial storage or disposal facility receives an off-site shipment of PCB waste accompanied by a manifest, the owner or operator, or their agent, shall:</P>
                        <STARS/>
                        <P>(b) If a commercial storage or disposal facility receives, from a rail or water (bulk shipment) transporter, PCB waste which is accompanied by a shipping paper containing all the information required on the manifest (excluding the EPA identification numbers, generator's certification, and signatures), the owner or operator, or their agent, must:</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>27. Amend § 761.214 by revising paragraph (a)(1) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.214</SECTNO>
                        <SUBJECT> Retention of manifest records.</SUBJECT>
                        <P>(a)(1) A generator must keep a copy of each manifest signed in accordance with § 761.210(a) for three years or until they receive a signed copy from the designated facility which received the PCB waste. This signed copy must be retained as a record for at least three years from the date the waste was accepted by the initial transporter. A generator subject to annual document requirements under § 761.180 shall retain copies of each manifest for the period required by § 761.180(a).</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>28. Amend § 761.216 by revising introductory paragraph (a) and paragraph (6) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.216</SECTNO>
                        <SUBJECT> Unmanifested waste report.</SUBJECT>
                        <P>(a) If a facility accepts for storage or disposal any PCB waste from an offsite source without an accompanying manifest, or without an accompanying shipping paper as described by § 761.211(e), and the owner or operator of the commercial storage or disposal facility cannot contact the generator of the PCB waste, then they shall notify the Regional Administrator of the EPA region in which their facility is located of the unmanifested PCB waste so that the Regional Administrator can determine whether further actions are required before the owner or operator may store or dispose of the unmanifested PCB waste, and additionally the owner or operator must prepare and submit a letter to the Regional Administrator within 15 days after receiving the waste. The unmanifested waste report must contain the following information:</P>
                        <STARS/>
                        <P>(6) Signature of the owner or operator of the facility or their authorized representative; and</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>29. Amend§ 761.217 by revising paragraph (a)(2)(ii) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.217</SECTNO>
                        <SUBJECT> Exception reporting.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>(2) * * *</P>
                        <P>(ii) A cover letter signed by the generator or their authorized representative explaining the efforts taken to locate the PCB waste and the results of those efforts.</P>
                        <STARS/>
                    </SECTION>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart M—Determining a PCB Concentration for Purposes of Abandonment or Disposal of Natural Gas Pipeline: Selecting Sites, Collecting Surface Samples, and Analyzing Standard PCB Wipe Samples</HD>
                    </SUBPART>
                    <AMDPAR>30. Amend § 761.243 by revising paragraph (a) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.243</SECTNO>
                        <SUBJECT> Standard wipe sample method and size.</SUBJECT>
                        <P>
                            (a) Collect a surface sample from a natural gas pipe segment or pipeline section using a standard wipe test as defined in § 761.123. Detailed guidance for the entire wipe sampling process appears in the document entitled, “Wipe Sampling and Double Wash/Rinse Cleanup as Recommended by the Environmental Protection Agency PCB Spill Cleanup Policy,” dated June 23, 1987 and revised on April 18, 1991. This document is available on EPA's website at 
                            <E T="03">https://www.epa.gov/pcbs,</E>
                             or from the Program Implementation and Information Division, Office of Resource Conservation and Recovery (5303P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>
                        31. Amend § 761.247 by revising paragraph (b)(2)(ii)(B)
                        <E T="03">(2)</E>
                         to read as follows:
                    </AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.247</SECTNO>
                        <SUBJECT> Sample site selection for pipe segment removal.</SUBJECT>
                        <P>(b) * * *</P>
                        <P>(2) * * *</P>
                        <P>(ii) * * *</P>
                        <P>(B) * * *</P>
                        <P>
                            <E T="03">(2)</E>
                             Divide the total number of segments in a pipeline, save one, by six. The resulting number is the interval between the segments you will sample. Do not round this interval. For example, cut a 2.9-mile length of pipeline into segments of no more than 40 feet by first, dividing 2.9 miles (15,312 feet) by 40 feet per segment, resulting in 382.8 total segments. Do not round this result. Subtract 1 from the total number of segments and then divide the remaining number of segments, 381.8, by six. The resulting number in this example is 63.6. Do not round. Add 63.6 to the first segment (number 1) to select segment 64.6. Next, add 63.6 to 64.6 to select segment 128.3. Continue in this fashion to select all seven segments: 1, 64.6, 128.3, 191.9, 255.5, 319.2, and 382.8. Now round these numbers to the nearest whole number to determine which segment to sample: 1, 65, 128, 192, 256, 319, and 383.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>32. Amend § 761.253 by revising paragraph (a) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.253</SECTNO>
                        <SUBJECT> Chemical analysis</SUBJECT>
                        <P>(a) Select applicable method(s) from the following list to extract PCBs and determine the PCB concentration from the standard wipe sample collection medium: SW-846 Method 3540C, Method 3541, Method 3545A, Method 3546, Method 8082, Method 8082A, Method 8275A, or CWA Method 1668C (all incorporated by reference, see § 761.19). Modifications to the methods listed in this paragraph or alternative methods not listed may be used if validated under Subpart Q of this part or authorized in a § 761.61(c) approval.</P>
                        <STARS/>
                    </SECTION>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart N—Cleanup Site Characterization Sampling for PCB Remediation Waste in Accordance with § 761.61(a)(2)</HD>
                    </SUBPART>
                    <AMDPAR>33. Amend § 761.267 by revising paragraph (a) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.267</SECTNO>
                        <SUBJECT> Sampling non-porous surfaces.</SUBJECT>
                        <P>(a) Sample large, nearly flat, non-porous surfaces by dividing the surface into roughly square portions approximately 2 meters on each side. Follow the procedures in § 761.302(a) with the exception of the sampling grid size.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>34. Revise § 761.272 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.272</SECTNO>
                        <SUBJECT> Chemical extraction and analysis of samples.</SUBJECT>
                        <P>
                            Select applicable method(s) from the following list to extract PCBs and determine the PCB concentration from individual and composite samples of PCB remediation waste: SW-846 Method 3510C, Method 3520C, Method 3535A, Method 3540C, Method 3541, Method 3545A, Method 3546, Method 8082, Method 8082A, Method 8275A, or CWA Method 1668C (all standards incorporated by reference in § 761.19). 
                            <PRTPAGE P="58762"/>
                            Modifications to the methods listed in this paragraph or alternative methods not listed may be used if validated under Subpart Q of this part or authorized in a 40 CFR 761.61(c) approval.
                        </P>
                    </SECTION>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart O—Sampling To Verify Completion of Self-Implementing Cleanup and On-site Disposal of Bulk Remediation Waste and Porous Surfaces in Accordance with § 761.61(a)(6)</HD>
                    </SUBPART>
                    <AMDPAR>35. Revise § 761.292 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.292</SECTNO>
                        <SUBJECT> Chemical extraction and analysis of individual samples and composite samples.</SUBJECT>
                        <P>Select applicable method(s) from the following list to extract PCBs and determine the PCB concentration from individual and composite samples of PCB remediation waste: SW-846 Method 3510C, Method 3520C, Method 3535A, Method 3540C, Method 3541, Method 3545A, Method 3546, Method 8082, Method 8082A, Method 8275A, or CWA Method 1668C (all standards incorporated by reference in § 761.19). Modifications to the methods listed in this paragraph or alternative methods not listed may be used if validated under Subpart Q of this part or authorized in a 761.61(c) approval.</P>
                    </SECTION>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart P—Sampling Non-Porous Surfaces for Measurement-Based Use, Reuse, and On-site or Off-Site Disposal Under § 761.61(a)(6) and Determination Under § 761.79(b)(3)</HD>
                        <STARS/>
                    </SUBPART>
                    <AMDPAR>35. Revise § 761.314 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.314</SECTNO>
                        <SUBJECT> Chemical analysis of standard wipe test samples.</SUBJECT>
                        <P>
                            Perform the chemical analysis of standard wipe test samples in accordance with § 761.253. Report sample results in micrograms per 100 cm
                            <SU>2</SU>
                            .
                        </P>
                    </SECTION>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart R—Sampling Non-Liquid, Non-Metal PCB Bulk Product Waste for Purposes of Characterization for PCB Disposal in Accordance with § 761.62, and Sampling PCB Remediation Waste Destined for Off-Site Disposal, in Accordance With § 761.61</HD>
                    </SUBPART>
                    <AMDPAR>36. Revise § 761.358 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.358</SECTNO>
                        <SUBJECT> Determining the PCB concentration of samples of waste.</SUBJECT>
                        <P>Select applicable method(s) from the following list to extract PCBs and determine the PCB concentration from individual and composite samples of PCB remediation waste or PCB bulk product waste: SW-846 Method 3540C, Method 3541, Method 3545A, Method 3546, Method 8082, Method 8082A, Method 8275A, or CWA Method 1668C (all incorporated by reference, see § 761.19). Modifications to the methods listed in this paragraph or alternative methods not listed may be used if validated under subpart Q of this part or authorized in a § 761.61(c) or § 761.62(c) approval.</P>
                    </SECTION>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart T—Comparison Study for Validating a New Performance-Based Decontamination Solvent Under § 761.79(d)(4)</HD>
                    </SUBPART>
                    <AMDPAR>37. Amend § 761.386 by revising paragraph (e) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.386</SECTNO>
                        <SUBJECT> Required experimental conditions for the validation study and subsequent use during decontamination.</SUBJECT>
                        <STARS/>
                        <P>
                            (e) 
                            <E T="03">Confirmatory sampling for the validation study.</E>
                             Select surface sample locations using representative sampling or a census. Sample a minimum area of 100 cm
                            <SU>2</SU>
                             on each individual surface in the validation study. Measure surface concentrations using the standard wipe test, as defined in § 761.123, from which a standard wipe sample is generated for chemical analysis. Guidance for wipe sampling appears in the document entitled “Wipe Sampling and Double Wash/Rinse Cleanup as Recommended by the Environmental Protection Agency PCB Spill Cleanup Policy,” available on EPA's website at 
                            <E T="03">https://www.epa.gov/pcbs,</E>
                             or from the Program Implementation and Information Division, Office of Resource Conservation and Recovery (5303P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>38. Amend § 761.395 by revising paragraph (b)(1) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 761.395</SECTNO>
                        <SUBJECT> A validation study.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(1) Select applicable method(s) from the following list to extract PCBs and determine the PCB concentration from the standard wipe sample collection medium: SW-846 Method 3540C, Method 3541, Method 3545A, Method 3546, Method 8082, Method 8082A, Method 8275A, or CWA Method 1668C (all incorporated by reference, see § 761.19). Modifications to the methods listed in this paragraph or alternative methods not listed may be used if validated under subpart Q of this part.</P>
                        <STARS/>
                    </SECTION>
                </SUPLINF>
                <FRDOC>[FR Doc. 2021-19305 Filed 10-21-21; 8:45 am]</FRDOC>
                <BILCOD>BILLING CODE 6560-50-P</BILCOD>
            </PRORULE>
        </PRORULES>
    </NEWPART>
</FEDREG>
